MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-09-02 for BEACON TIP ANGLED SELECTIVE SALPINGOGRAPHY CATHETER N/A J-SSG-504000 manufactured by Cook Urological Inc.
[24876581]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[24876582]
During a fallopian tube catheter recanalization procedure on a (b)(6) female patient with fallopian tube occlusion, the beacon-tip separated intrauterine during the sonosalpingography procedure. The doctor removed the catheter and wire guide together by use of a vascular clamp inserted into the intrauterine. A second procedure was performed with a product from another manufacturer. A section of the device did not remain inside the patient's body. According to the initial reporter, the patient did not experience any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[34540281]
(b)(4). Event evaluation: a functional test along with a review of the complaint history, device history record, instructions for use (ifu), quality control and a visual inspection of the returned products were conducted during the investigation. One open and seven unopened and sealed products from the complaint lot were returned. Visual exam of the used device confirmed the tip had circumferentially split approximately 3mm distal of the bond joint. Functional testing using minimal pressure on one of the seven sealed catheters was able to re-create the damage, in the same location, as the complaint device. But for the split area, the remaining material was pliable. Microscopic examination of the split tips noted the inner diameter material to be brittle and degraded. There is no evidence to suggest that the product was not manufactured to specifications. This product is shipped with an ifu which states under storage and handling instructions: "avoid extended exposure to light. " / warnings: "due to thin wall construction of this catheter, extreme care must be exercised during manipulation and withdrawal to prevent pulling the catheter apart. Reshaping of the tip is not recommended. Damage can result when exposed to heat. " we are unable to determine with certainty the root cause for this experienced failure mode. The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[34540282]
During a fallopian tube catheter recanalization procedure on a (b)(6) year old female patient with fallopian tube occlusion, the beacon-tip separated intrauterine during the sonosalpingography procedure. The doctor removed the catheter and wire guide together by use of a vascular clamp inserted into the intrauterine. A second procedure was performed with a product from another manufacturer. A section of the device did not remain inside the patient's body. According to the initial reporter, the patient did not experience any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2015-00552 |
| MDR Report Key | 5050703 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-09-02 |
| Date of Report | 2015-08-10 |
| Date of Event | 2015-08-07 |
| Date Facility Aware | 2015-08-07 |
| Date Mfgr Received | 2015-08-10 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2015-09-02 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEACON TIP ANGLED SELECTIVE SALPINGOGRAPHY CATHETER |
| Generic Name | MOV CATHETER, SALPINGOGRAPHY |
| Product Code | MOV |
| Date Received | 2015-09-02 |
| Returned To Mfg | 2015-09-01 |
| Model Number | N/A |
| Catalog Number | J-SSG-504000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 22 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC |
| Manufacturer Address | 1100 WEST MORGAN ST SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-02 |