MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-03-20 for RING DRAINAGE CATHETER NEEDLE SET DLPN-40-25-RING manufactured by Cook, Inc..
[17561226]
The pt was in interventional radiology for embolization of an abdominal aortic aneurysm endoleak. After multiple attempts the ring drainage catheter fractured and 10 cm of the catheter was left in the pt. Unsuccessful attempts were made to retrieve the retained catheter. Info received on (b)(6) 2012, by risk management at the facility: the fractured device still remains in the pt. The pt is stable and has been released from the hospital. The physician is following up and monitoring the pt.
Patient Sequence No: 1, Text Type: D, B5
[17819917]
(b)(6). Although requested, the complaint device was not returned to assist in our investigation. However, the complaint is confirmed per the customer's testimony. Quality control verifies the surface of the catheter is clean and free of damage. The strength and elongation of a sample of each lot of tubing are verified as well. Without the actual complaint device it is difficult to determine what may have led to this failure. However, it is possible that the device met resistance beyond its design. We have notified the appropriate internal personnel and will continue to monitor for similar complaints. Per the conclusion of quality engineering risk assessment, no further mitigating action is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2012-00150 |
| MDR Report Key | 2537792 |
| Report Source | 00 |
| Date Received | 2012-03-20 |
| Date of Report | 2012-02-23 |
| Date of Event | 2012-02-07 |
| Report Date | 2012-02-01 |
| Date Reported to FDA | 2012-02-01 |
| Date Mfgr Received | 2012-02-24 |
| Device Manufacturer Date | 2010-07-27 |
| Date Added to Maude | 2012-04-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MGR. |
| 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 | RING DRAINAGE CATHETER NEEDLE SET |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2012-03-20 |
| Model Number | NA |
| Catalog Number | DLPN-40-25-RING |
| Lot Number | 2543138 |
| ID Number | NA |
| Device Expiration Date | 2013-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-20 |