MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-12-06 for SKATER CATHETER UNK NA manufactured by Angiotech, Medical Device Technologies.
[2443393]
Md states that upon removal of a skater all purpose catheter, the nylon suture became detached and was left in the pt. Surgical procedure required to remove the suture material.
Patient Sequence No: 1, Text Type: D, B5
[9559152]
The customer states the suture became detached and was left in the pt. No sample is available for review. The part number and lot number for the catheter used was not known by the reporter. The reporter states this is a common occurrence on their end; however, this time both ends of the suture were dropped and the suture was lost inside the pt. The ifu for the product states to check that both threads are loose and cut one thread in order to loosen the pigtail. Only one end of the suture should be cut so that the tab is still attached and used as an anchor. Per f/u with the customer the suture has been removed from the pt. We will continue to monitor and trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036710-2011-00015 |
| MDR Report Key | 2366291 |
| Report Source | 06 |
| Date Received | 2011-12-06 |
| Date of Report | 2011-11-15 |
| Date of Event | 2011-11-15 |
| Date Mfgr Received | 2011-10-10 |
| Date Added to Maude | 2012-07-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHANNON BROOKS, SR ANALYST |
| Manufacturer Street | 3600 S.W. 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523380440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKATER CATHETER |
| Generic Name | ALL PURPOSE DRAINAGE CATHETER |
| Product Code | GBQ |
| Date Received | 2011-12-06 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES |
| Manufacturer Address | 3600 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-06 |