MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08,distributor,foreign report with the FDA on 2015-07-31 for BEACON TIP ANGLED SELECTIVE SALPINGOGRAPHY CATHETER N/A J-SSG-504000 manufactured by Cook Inc.
[6639972]
During a fallopian tube recanalization procedure on a (b)(6) female patient with bilateral fallopian tube obstruction, the tip of the catheter broke/separated inside the patient's uterine cavity. The broken tip were removed from the patient by forceps holder. Per information provided to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[14306519]
(b)(4). Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[35332922]
(b)(4). **** event evaluation **** a review of complaint history, device history record, instructions for use (ifu), quality control and a visual examination of the returned product was conducted during the investigation. A visual inspection of the opened and used device noted that the distal tip of that catheter had separated circumferentially ~1 cm from the bond site. The split tips id material appeared brittle and degraded. With exception to the split material, the remaining tip material was pliable. 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 why this failure mode occurred. The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[35332923]
During a fallopian tube recanalization procedure on a (b)(6) year old female patient with bilateral fallopian tube obstruction, the tip of the catheter broke/separated inside the patient's uterine cavity. The broken tips were removed from the patient by forceps holder. Per information provided to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2015-00481 |
| MDR Report Key | 4964015 |
| Report Source | 01,08,DISTRIBUTOR,FOREIGN |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-27 |
| Date of Event | 2015-07-24 |
| Date Facility Aware | 2015-07-24 |
| Report Date | 2015-07-27 |
| Date Mfgr Received | 2015-07-27 |
| Device Manufacturer Date | 2013-10-11 |
| Date Added to Maude | 2015-08-05 |
| 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 | 2015-07-31 |
| Returned To Mfg | 2015-08-13 |
| Model Number | N/A |
| Catalog Number | J-SSG-504000 |
| Lot Number | U2409898 |
| ID Number | N/A |
| Device Expiration Date | 2016-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-31 |