MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-05-07 for CONE TIP URETERAL CATHETER 8 FR 334108 manufactured by Rusch, Inc..
[7764003]
Evidence of good bond was found on the shaft and the alleged cone tip found to be misshaped and cracked. Excessive force could have been used to cause this. Exact cause of this incidence can not be determined.
Patient Sequence No: 1, Text Type: N, H10
[17431447]
It was reported that the tip of the catheter came off in the ureter while performing ureteroscopy. The tip was retrieved. No injuries to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1998-00019 |
| MDR Report Key | 166518 |
| Report Source | 05,06 |
| Date Received | 1998-05-07 |
| Date of Report | 1998-05-07 |
| Date of Event | 1998-04-22 |
| Date Mfgr Received | 1998-04-27 |
| Date Added to Maude | 1998-05-12 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONE TIP URETERAL CATHETER 8 FR |
| Generic Name | URETERAL CATHETER |
| Product Code | FGF |
| Date Received | 1998-05-07 |
| Model Number | NA |
| Catalog Number | 334108 |
| Lot Number | 807050 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 162042 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | CONE TIP URETERAL 8FR |
| Baseline Generic Name | URETERAL CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 334108 |
| Baseline ID | NA |
| Baseline Device Family | URETERAL CATHETERS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-07 |