MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-29 for COOK COPE-LOOP CATHETER 085110 manufactured by Cook Inc.
[129344563]
(b)(6). (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[129344565]
It was reported, on "many occasions", the cook cope-loop catheters are being removed from patients kidneys as per instruction for use (ifu), however, the tether at times is left behind in the patient and is then having to be removed. The customer was unable to confirm how may patients were involved with this issue. The patients involved where post-surgery who had the catheters removed in the hospital ward. Remaining tether was removed by nurses by hand. The patient did not require any additional procedures. The patient did not experience an adverse event. Additional information has been requested regarding the event. At the time of this report, no further information has been provided. Update 26nov2018: email sent to area rep ((b)(6)) to follow up on additional information that has been requested. Also requested information on how long stent was in place prior to removal. 26nov2018 (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03440 |
| MDR Report Key | 8115498 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-29 |
| Date of Report | 2019-01-08 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2018-11-29 |
| 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 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK COPE-LOOP CATHETER |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2018-11-29 |
| Catalog Number | 085110 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-11-29 |