MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2001-03-28 for TREROTOLA GASTROSTOMY TRACT DILATION SET GTDS-24-8-10-0 manufactured by Cook, Inc..
[224555]
With an amplatz stiff wire and the balloon catheter fixed securely, the staff was attempting to place the sheath over the inflated balloon catheter and wire combination. During the attempt, the catheter broke at the junction of the balloon. The balloon remained partially inflated and could not be pulled back through the sheath. The broken catheter segment was snared and retrieved without further difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2001-00028 |
| MDR Report Key | 322641 |
| Report Source | 05,07 |
| Date Received | 2001-03-28 |
| Date of Report | 2001-02-28 |
| Report Date | 2001-02-28 |
| Date Mfgr Received | 2001-02-28 |
| Device Manufacturer Date | 2000-12-01 |
| Date Added to Maude | 2001-03-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DENNIS TROY |
| Manufacturer Street | 925 SOUTH CURRY PIKE |
| Manufacturer City | BLOOMINGTON IN 47403 |
| Manufacturer Country | US |
| Manufacturer Postal | 47403 |
| 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 | TREROTOLA GASTROSTOMY TRACT DILATION SET |
| Generic Name | SPECIAL SET |
| Product Code | GCC |
| Date Received | 2001-03-28 |
| Model Number | NA |
| Catalog Number | GTDS-24-8-10-0 |
| Lot Number | F989039 |
| ID Number | NA |
| Device Expiration Date | 2003-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 312104 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 925 SOUTH CURRY PIKE BLOOMINGTON IN 47403 US |
| Baseline Brand Name | TREROTOLA GASTROSTOMY TRACT DILATION SET |
| Baseline Generic Name | SPECIAL SET |
| Baseline Model No | NA |
| Baseline Catalog No | GTDS-24-8-10-0 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-03-28 |