MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-10-19 for AMPLATZ ANCHOR? M001221000 22-100 manufactured by Boston Scientific - Costa Rica (coyol).
[57866598]
Age at the time of event: 18 years or older. (b)(4). Device evaluated by mfr. : the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57866599]
It was reported that removal difficulties occurred and patient experienced pain. The target area was located in the biliary tract. An amplatz anchor was used. Upon removal of the drain from the patient's body, the end part of the catheter became stuck at the string and the loop was not released. The catheter was then forcibly pulled from the patient; consequently, the patient experienced pain. There were no further patient complications reported and the patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5
[61646609]
Device evaluated by mfr: the device was returned for analysis. Visual inspection of the device revealed that the suture was broken, and its proximal section was ripped/torn. No other anomalies or damages. A mandrel of 0. 038 inches was inserted through the catheter and passed properly without resistance upon functional testing. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61646610]
It was reported that removal difficulties occurred and patient experienced pain. The target area was located in the biliary tract. An amplatz anchor? Was used. Upon removal of the drain from the patient's body, the end part of the catheter became stuck at the string and the loop was not released. The catheter was then forcibly pulled from the patient; consequently, the patient experienced pain. There were no further patient complications reported and the patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5
[62807200]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62807201]
It was reported that removal difficulties occurred and patient experienced pain. The target area was located in the biliary tract. An amplatz anchor was used. Upon removal of the drain from the patient's body, the end part of the catheter became stuck at the string and the loop was not released. The catheter was then forcibly pulled from the patient; consequently, the patient experienced pain. There were no further patient complications reported and the patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2016-09760 |
| MDR Report Key | 6041336 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-10-19 |
| Date of Report | 2016-10-11 |
| Date of Event | 2016-10-07 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2016-10-19 |
| 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 | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZ ANCHOR? |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2016-10-19 |
| Returned To Mfg | 2016-10-21 |
| Model Number | M001221000 |
| Catalog Number | 22-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-19 |