MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2013-02-15 for PERCUTANEOUS MALECOT NEPHROSTOMY CATHETER SET 082014-ET manufactured by Cook Urological, Inc..
[3173323]
Nephrostomy was performed due to stenosis of lower part of ureter. During the procedure, kidney was punctured with the needle and the wire guide was inserted as prescribed. When the wire guide was advanced to lower part of ureter via ureteropelvic junction from middle calyx of kidney, the wire guide was manipulated. However, the wire guide was not controlled as intended and the wire guide tip was caught by the needle tip. The physician attempted to retract the wire guide and the tip part was separated. Consequently, the tip of the wire guide remained in the pt. The physician understands this kind of event is a well known issue. He also mentions the tip of the wire guide tangled with clot inside kidney and it caused tension. The tension interfered in removing the wire guide. Another wire guide was used and the procedure was completed. No adverse symptom was observed. On (b)(6) 2013, additional information was provided to the mfr which determined the reportability of this event. Additional procedure was performed to retrieve the tip of the wire guide on (b)(6) 2012. However, it was not valid since the piece was only visible under fluoroscopic control and was not observed during the procedure using an endoscope. The physician thinks the piece is in the mucous membrane. The piece was remained in the pt.
Patient Sequence No: 1, Text Type: D, B5
[10524089]
Lot number unk as not provided by the reporter. Expiration date unk as not provided by the reporter. Information not provided by the reporter. (b)(4). Complaint device was not returned to assist in the investigation. During our investigation, a review of complaint history, review of ifu, and review of specifications was performed. A review of the device history record for this device did not indicate any nonconformances for this lot number, current controls and component specifications are in place to assure device integrity prior to transportation. An ifu is provided that has instructions for use of the needle, and wireguide placement. Without the product being returned, we are unable to determine why this difficulty may have been experienced. However, the appropriate personnel have been notified of this incident and we will continue to monitor this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00099 |
| MDR Report Key | 2985313 |
| Report Source | 01,06,08 |
| Date Received | 2013-02-15 |
| Date of Report | 2012-11-13 |
| Report Date | 2012-11-13 |
| Date Mfgr Received | 2012-11-14 |
| Date Added to Maude | 2013-03-04 |
| 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 | RITA HARDEN, MANAGER |
| 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 | PERCUTANEOUS MALECOT NEPHROSTOMY CATHETER SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2013-02-15 |
| Model Number | NA |
| Catalog Number | 082014-ET |
| Lot Number | UNK |
| 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 UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-02-15 |