MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-11-25 for SKINNY NEEDLE PERCUTANEOUS ENTRY NEEDLE 090010 manufactured by Cook Urological, Inc..
[1451626]
During a percutaneous nephrostomy with fluoroscopic guidance, a 0. 038 / 150cm nitinol guidewire with hydrophilic coating (bard device) was inserted through a 20 gauge skinny needle with chiba tip. As the guidewire was pulled back to re-direct to the correct location within the kidney, resistance was felt. The guidewire was removed with some resistance and a new one was inserted through the same needle. Resistance was met when pulling the wire back into the needle. A third guidewire was used, and the resistance was felt again. Ultimately, a nephrostomy tube was placed in the renal pelvis. Three weeks later, a percutaneous lithotripsy was done and four days after that a nephrostogram was performed. On the scout film, a foreign body was seen in the distal ureter. Under general anesthesia, the foreign body was removed. The urologist identified the foreign body as the hydrophilic coating that is over the guidewire. The pathologist identified the specimen as "four threadlike fragment 1 cm to 4 cm in length, and a tan-white fragment - 0. 5cm. " removal of foreign body.
Patient Sequence No: 1, Text Type: D, B5
[8333925]
A proper eval cannot be performed due to not being provided the device, lot # or part # for the incident. Upon contacting risk mgmt to obtain additional info, the contact had stated any additional info requested would have to be put into writing noting three requests have been sent without response. In reviewing the specifications for a cook 20ga skinny needle, the inside diameter would not allow an. 038" wireguide to be placed inside the needle. Additionally, when using a polymer coated wireguide through a needle, care should be taken to assure the wireguide is not angled causing the needle bevel to scrape or cut the polymer coating off of the wireguide. Upon receipt of additional info, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2009-00037 |
| MDR Report Key | 1546778 |
| Report Source | 06 |
| Date Received | 2009-11-25 |
| Date of Event | 2009-08-13 |
| Report Date | 2009-10-06 |
| Date Mfgr Received | 2009-10-27 |
| Date Added to Maude | 2009-12-03 |
| 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 | CHRIS KILANDER |
| Manufacturer Street | 1100 WEST MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKINNY NEEDLE PERCUTANEOUS ENTRY NEEDLE |
| Generic Name | FHR NEEDLE, GASTRO-UROLOGY |
| Product Code | FHR |
| Date Received | 2009-11-25 |
| Model Number | NA |
| Catalog Number | 090010 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-11-25 |