MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2019-12-23 for BARD? X-FORCE? NEPHROSTOMY BALLOON DILATION CATHETER 996101 manufactured by C.r. Bard, Inc. (covington) -1018233.
[172600990]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Patient Sequence No: 1, Text Type: N, H10
[172600991]
It was reported that an x-force balloon dilating catheter spontaneously deflated. It developed a leak during dilation of the nephrostomy tract in a male patient who underwent percutaneous nephrostolithotomy for obstructive uropathy and a 1. 5 cm stone. The balloon catheter was exchanged, and it was noted that at the 6 cm distal point, the balloon was no longer attached to the catheter. The balloon was separated from the catheter and trapped, with contrast in the balloon, within the nephrostomy tract. A second incision was made. An interventional radiologist assisted with multiple attempts to snare and retrieve the balloon with multiple wire placements through the second incision for about 45 minutes, unsuccessfully. After the nephroscopy was performed and the stone was removed, a nephroscope was performed to look for the fractured, retained balloon fragment in the renal pelvis and it could not be found. It was imaged with c-arm and seen in the nephrostomy tract. The sheath was then maneuvered out of the nephrostomy tract until it was possible to visualize the fractured fragment outside of the renal parenchyma within what appeared to be gerota? S fascia or the retroperitoneum. Multiple attempts were again made to engage the fragment; however, it would not migrate when it was pulled, despite the use of multiple devices and that it was clearly visualized and engaged. During an exchange of instrumentation, the nephroscope was re-introduced under fluoroscopy and it was possible to see that the distal portion was still retained. Additional information was received the patient had a left vats extraction of the left pleural cavity to remove the foreign body. The procedure was successful and the patient tolerated it well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-08184 |
| MDR Report Key | 9511864 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2019-12-23 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-10-29 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-04-18 |
| Date Added to Maude | 2019-12-23 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? X-FORCE? NEPHROSTOMY BALLOON DILATION CATHETER |
| Generic Name | NEPHROSTOMY CATHETER |
| Product Code | LJE |
| Date Received | 2019-12-23 |
| Returned To Mfg | 2020-01-16 |
| Catalog Number | 996101 |
| Lot Number | BMDQFM19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-23 |