MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2004-09-30 for MALECOT CATHETER ULT10.2-38-25-P-NS-ASM-WF manufactured by Cook, Inc..
[20205219]
The device, which was placed for drainage of a subdiaphragmatic abscess, was removed with a. 035 radifocus and without using a stylet at post-op day five. The physician stated that he felt no resistance during removal, however, upon removal, noted the blue tip of the catheter missing. The fragment tip was observed in the subdiagphragmatic region. An incision was made and the fragmented tip was removed via forceps. However, this resulted in the development of penumothorax, necessitating placement of another drainage catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2004-00600 |
| MDR Report Key | 546967 |
| Report Source | 01,05,08 |
| Date Received | 2004-09-30 |
| Date of Report | 2004-09-07 |
| Date of Event | 2004-08-03 |
| Date Facility Aware | 2004-09-03 |
| Report Date | 2004-09-07 |
| Date Mfgr Received | 2004-09-07 |
| Date Added to Maude | 2004-10-05 |
| 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 | RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALECOT CATHETER |
| Generic Name | CATHETER |
| Product Code | FEW |
| Date Received | 2004-09-30 |
| Returned To Mfg | 2004-09-21 |
| Model Number | NA |
| Catalog Number | ULT10.2-38-25-P-NS-ASM-WF |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 536375 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Baseline Brand Name | MALECOT CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | ULT10.2-38-25-P-NS-ASM-WF |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-30 |