MAUDE Adverse Event Report: COVIDIEN (IRVINE) GUIDEWIRE .014; WIRE, GUIDE, CATHETER

Model Number	203-0602-200
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The x-pedion-14 guidewire was returned for analysis.The x-pedion-14 guidewire was removed from within the dispenser coil for further evaluation.No bends or kinks were found with the pushwire.The x-pedion-14 guidewire coating was found to be scrapped and missing from the distal end.The remaining guidewire coating was found to be intact and well adhered to the wire surface with no evidence of delamination.Dried residue (possibly blood and/or contrast) was found on the guidewire proximal solder region.The guidewire outer coils were found to be stretched at proximal solder region with the inner core wire broken at the proximal solder region.The guidewire outer coils at the distal tip were found to be stretched and damaged.The distal broken end of the inner core wire was found within the damaged distal tip.The x-pedion-14 broken inner core wire was sent out for scanning electron microscopy (sem) analysis.No other anomalies were observed.Images relevant to this complaint were not available for review and a sample of the ¿greenish water¿ from the event was not provided.The x-pedion-14 guidewire coating was found to be scrapped and missing.The remaining guidewire coating was found to be intact and well adhered to the wire surface with no evidence of delamination.Based on the device analysis and reported information, the report could not be confirmed as the source of the ¿greenish water¿ could not be determined.However, it is possible scrapings from the x-pedion-14 guidewire coating may have contributed to the issue.The pushwire coating damage appears to have been caused by mechanical scraping and abrasion.Mechanical scraping can be caused during manipulation of the guidewire with a metal torque device (pin vise) and/or with an introducer needle.However, the cause for the coating damage could not be determined at this time.Based on the investigation conducted, coating separation can be caused by several factors, including but are not limited to procedural factors, highly tortuous patient¿s anatomy, device compatibility issues, improper conditioning, device storage conditions as well as design or manufacturing processes related issues.Since the remaining coating was intact, the issue was most likely use related rather than a failure or fault condition of the coating.The returned x-pedion-14 guidewire was also found to be broken.However, the cause could not be determined at this was not reported by the user.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that when the x-pedion guidewire was introduced into water, the water turned a greenish color.It was noted there was no solutions in the water, and no other devices were placed in the water prior to submerging the x-pedion guidewire.Another microguide was used to treat the patient.No patient injury occurred.

• Brand Name: GUIDEWIRE .014
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8274252
• Report Number: 2029214-2019-00051
• Device Sequence Number: 16506126
• Product Code: DQX
• UDI-Device Identifier: 00847536006362
• UDI-Public: 00847536006362
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K001454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2020
• Device Model Number: 203-0602-200
• Device Lot Number: 201711061E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 80