MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-15 for UNKNOWN manufactured by Halyard - Irvine.
[40643645]
(b)(4) udi # unknown. Method: the device was not reported as available for return and analysis. The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted. Results: as the device and lot number were unavailable for analysis, no methods were performed. For this reason results cannot be obtained. Conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event. The instructions for use (ifu) specifies the following: "grasp catheter close to skin and gently pull to remove. The catheter should be easy to remove and not painful. Do not tug or quickly pull on catheter during removal (figure 11 on page 2). Cautions: if resistance is encountered or catheter stretches, stop. Continued pulling could break the catheter. It? S advisable to cover the site with warm compresses, and wait 30 to 60 minutes, and try again. The patient? S body movements may relieve the catheter to allow easier removal. For additional information refer to the technical bulletin: tips for preventing in-situ catheter breakage with the on-q* system. Do not cut or forcefully remove catheter. " information from this incident has been included in our product complaint and mdr trend reporting systems. Trend information is used to identify the need for additional investigations. .
Patient Sequence No: 1, Text Type: N, H10
[40643646]
Procedure: left leg subtalar fusion cathplace: along the sciatic nerve in the upper leg just proximal to the knee. It was reported by the patient's representative who alleged "the defect described as "retained hardware. ""; "upon attempted extraction per instructions, part of the plastic portion of the catheter had removed. But the metal implant remained in [patient's] leg. " the physician's report of the operation dated (b)(6) 2015 stated "the catheter was noted to go through the fascia. It appeared that some of the coils of the metal were entrapped within the fascia. We bluntly dissected through this area, freeing it from the muscle tissues down to the level of the sciatic nerve, where we could see the blunt tip directly opposed to the sciatic nerve. The wire was then extracted. " "the catheter plastic tip was compared to the same product off the shelf, and indeed it appeared that all the plastic catheter had actually exited the skin, but the only remaining portion was the wire fragment going down in towards the nerve. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2026095-2016-00016 |
| MDR Report Key | 5503020 |
| Date Received | 2016-03-15 |
| Date of Report | 2016-02-17 |
| Date of Event | 2015-10-17 |
| Date Mfgr Received | 2016-02-17 |
| Date Added to Maude | 2016-03-15 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT S. DE R.L. DE C.V. |
| Manufacturer Street | AVE NORUEGA EDIFICIO D-1B FRACCIONAMIENTO RUBIO |
| Manufacturer City | TIJUANA, B.C. 22116 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN |
| Generic Name | CATHETERS |
| Product Code | OFT |
| Date Received | 2016-03-15 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | HALYARD - IRVINE |
| Manufacturer Address | 43 DISCOVERY SUITE 100 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-15 |