MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-24 for IPAS MANUAL VACUUM ASPIRATION (MVA); IPAS EASY GRIP CANNULAE MMKSU manufactured by Womancare Global.
[75924570]
On 21 may 2017 - follow-up (from wcg requested information to distributor, sent on 28 april 2017): product information. Specific devices involved in the procedure - part number and/or product name of aspirator and cannula used. Wcg: are these devices available for return and evaluation? (b)(4): has already discarded. Wcg: are photos of the devices used in the procedure available? (b)(4): impossible because has discarded. Status of device prior to use. Wcg age of devices? (b)(4): no record. Wcg: condition of devices prior and after use (e. G. Breaks, brittle, etc. )? (b)(4): nothing recognize any problem of the device. Wcg: device preparation performed? (b)(4): yes, checked the product before use. Device performance during procedure wcg: any issues encountered? (b)(4): recognized a little bit difficult to insert the cannula. Wcg: did aspiration of any pregnancy tissue occur? (b)(4): aspirator didn't move when the doctor tried to move longitudinal direction under the suction pressure condition. Wcg: was the procedure completed with aspiration (manual or electric) or if not, how was the procedure completed? (b)(4): when moved the aspirator back and forth with the transabdominal ultrasound, the uterine tissue also moved together, so it was suspected uterine puncture and stopped surgery. Patient/procedure information. Wcg: name, title, address, phone of practitioner who performed procedure? (b)(4): no. Wcg: experience of practitioner performing procedure = 2 yrs? (b)(4): two year experiences of obstetrics and gynecology. (if include medical intern, 4 years experiences). Wcg: number of years of experience performing mva procedure) = < 1 yr, first time. (b)(4): first try for mva. Wcg: type of mva training provided? (b)(4): no operation experience. Learning from watching. Wcg: was dr. (b)(6) the physician who performed the mva procedure? If no - please kindly provide his position and role to the hospital. (b)(4): dr. (b)(6) didn't operate the treatment. His position is supervisor. ? Wcg: name, address and phone of facility where event occurred? (b)(4): has already informed (note: provided in initial report). Wcg: number of previous pregnancies = 1? (b)(4): has already informed. (note: provided in initial report). Wcg: gestational age of pregnancy = 6-7 weeks? (b)(4): not exactly, but remember such like this. Wcg: date of initial mva procedure performed? (b)(4): not remember, need to confirm the clinical records. Wcg: how many passes into the uterus occurred during the procedure? (b)(4): one or two. Wcg: what treatment/diagnostic testing was performed prior to first surgery (e. G. Anesthesia, ultrasound, ct scan, x-ray)? (b)(4): performed transvaginal sonography and missed at abortion diagnosis. Ketalar was used for anesthesia. Wcg: what treatment/diagnostic testing was performed after event? (b)(4): repair surgery and uterine content elimination were performed under the laparoscopic surgery. Because perforation in the body part of the uterine front wall under was recognized. Wcg: diagnostic test/procedure performed for verification of perforation? (b)(4): performed contrast ct and transabdominal ultrasound. Wcg: location in the uterus of the perforation? (anterior/posterior/fundal/midline/lateral). (b)(4): it was slightly from the uterus bottom of the uterine front wall. Wcg: date of procedure to resolve perforation? (b)(4): same day of mva operation. Wcg: procedure performed to resolve perforation? (b)(4): laparoscopic uterine perforation surgery. Wcg: medication administered? (b)(4): antibiotics and uterine contraction agent (methyl ergometrin) after operation. Wcg: date of release and follow-up? (b)(4): about three days after operation. ** wcg - comment from wcg qa: further investigation/evaluation of the reported mmksu devices (aspirator, cannulae) used in the mva procedure could not be performed as the product was not available for return/evaluation, and lot number information was not provided. Device malfunction does not appear to be the cause of the adverse event. Device was not made available.
Patient Sequence No: 1, Text Type: N, H10
[75924571]
On 20 april 2017 - initial report received by womancare global (wcg) womancare global was notified by (b)(4) distributor of ipas manual aspirator (mva), ipas easy grip and denniston dilators, (b)(4), of an adverse event that occurred during a mva procedure on (b)(6) 2017 (exact date was not provided) at (b)(6) hospital in (b)(6). The distributor received the adverse event report from dr. (b)(6), ob-gyn supervisor, at their vendor's booth during the (b)(6). Dr. (b)(6) reported that a suspected intra-operative perforation had occurred during a mva procedure to a (b)(6) patient with 6-7 weeks gestation. Distributor ((b)(4)) report (as received on 20 april 2017): age at 30's. 1 maternity (cesarean section performed at pelvic position several years ago). This time diagnosed as missed abortion at 6 to 7 w upon natural pregnancy. Surgery was performed by intravenous anesthesia with ketalar? (ketamine hydrochloride). In the preoperative usg, the lower uterine segment is somewhat thinned, and the uterus posterior flexion was strong. Cervical expansion with dilasoft? Prior to the operation. The surgery was performed under transabdominal ultrasound. The surgeon is the second year specialist of obstetrics and gynecology and he performed mva for the first time. Cervix was dilated with the denniston dilators in the mva kit. Then 8 mm or 9 mm cannulas was used. It seems there was a resistance when inserting but the surgeon continue inserting. When a negative pressure was applied, the cannula totally stuck and perforation was suspected. (in the subsequent consideration, it was determined that the cannula was aspirating the mesentery and this is why the surgeon lost motion of the cannula). Due to suspecting intra-operative perforation, mva surgery was discontinued and observed while. As abdominal pain persistence + ascetic fluid retention was confirmed uterine perforation was diagnosed. On the same day laparoscopically, uterine puncture repair operation + d&c was completed. The postoperative course was good and the patient was discharged the hospital on the fourth day of laparoscopic surgery. The woman's period is resumed and the recovery is well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008007615-2017-00002 |
| MDR Report Key | 6589552 |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-23 |
| Date Mfgr Received | 2017-04-20 |
| Date Added to Maude | 2017-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. KELLY CULWELL |
| Manufacturer Street | 12400 HIGH BLUFF DRIVE SUITE 600 |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal | 92130 |
| Manufacturer Phone | 8583144025 |
| Manufacturer G1 | PACIFIC HOSPITAL SUPPLY CO., LTD. |
| Manufacturer Street | NO. 19, TZI-CHIANG ROAD TORNG-LO INDUSTRIAL DISTRICT |
| Manufacturer City | MIAOLI, MIAOLI 366 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 366 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IPAS MANUAL VACUUM ASPIRATION (MVA); IPAS EASY GRIP CANNULAE |
| Generic Name | VACUUM ABORTION SYSTEM; CANNULA-SUCTION, PRODUCT CODE HHI |
| Product Code | HHI |
| Date Received | 2017-05-24 |
| Model Number | MMKSU |
| Catalog Number | MMKSU |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WOMANCARE GLOBAL |
| Manufacturer Address | 12400 HIGH BLUFF DRIVE SUITE 600 SAN DIEGO CA 92130 US 92130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-05-24 |