MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08,distributor,foreign report with the FDA on 2015-07-16 for PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET N/A 080008 manufactured by Cook Urological Inc..
[17851234]
According to the initial reporter, four incidents where it was impossible to implant/use the product regarding the percutaneous pigtail nephrostomy accessory set during a procedure on a single patient. The user had experienced difficulty advancing through the kidneys. At this time, it is unclear if any of these incidents may have led to repeated renal punctures, risks of kidney bruises, inability to implant during emergency situations and other unknown issues. Since the reporter has not indicated which of the four devices may have caused the adverse events, it was determined to report on this event as a side of caution. Additional information has been requested, however, it was not available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[18144671]
(b)(4). At this time it is unclear if any of these incidents may have led to repeated renal punctures, risk of kidney bruises, inability to implant during emergency. This event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[37071676]
(b)(4). Investigation: a review of the complaint history, documentation, quality control (qc), specifications, functional testing and a visual inspection of the complaint device was conducted for the purpose of this investigation. Three dilators (6, 7, and 8fr) and a cook malecot catheter from a percutaneous pigtail nephrostomy accessory set was returned for investigation. The wire guide from the set was not returned for investigation. A visual examination of the devices noted the tips of the dilators appeared split and stretched. A cook medical. 038? Ptfe wire guide was passed successfully through each of the dilators and the malecot. The current controls in place for manufacturing qc are in place to assure functionality and device integrity prior to transportation. Each packaged device is sent with instructions for use. There is no evidence to suggest that the device was not made to specification. It is likely that the physician was unable to gain adequate access of the kidney with the guide wire, however, with the information provided a definitive root cause cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[37071677]
According to the initial reporter, four incidents occurred where it was impossible to implant/use the product regarding the percutaneous pigtail nephrostomy accessory set during a procedure on a single patient. The user had experienced difficulty advancing through the kidneys. At this time, it is unclear if any of these incidents may have led to repeated renal punctures, risks of kidney bruises, inability to implant during emergency situations and other unknown issues. Since the reporter has not indicated which of the four devices may have caused the adverse events, it was determined to report on this event as a side of caution. Additional information has been requested, however it was not available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2015-00469 |
| MDR Report Key | 4924208 |
| Report Source | 01,08,DISTRIBUTOR,FOREIGN |
| Date Received | 2015-07-16 |
| Date of Report | 2015-06-18 |
| Date of Event | 2015-06-16 |
| Date Facility Aware | 2015-06-16 |
| Report Date | 2015-06-17 |
| Date Mfgr Received | 2015-06-22 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2015-07-21 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2015-07-16 |
| Returned To Mfg | 2015-07-09 |
| Model Number | N/A |
| Catalog Number | 080008 |
| Lot Number | U2383875 |
| ID Number | SEE H.10 |
| Device Expiration Date | 2016-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 22 MO |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2015-07-16 |