MAUDE Adverse Event Report: COVIDIEN (IRVINE) MIRAGE; WIRE, GUIDE, CATHETER

Model Number	103-0608
Medical Device Problem Code	Delamination (2904)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is undergoing an evaluation but has not yet been completed.A supplemental report will be filed.Mdr related to this event: 2029214-2017-00290, 2029214-2017-00291.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the guidewire coating was peeling when the device was navigated through the sheath.The event occurred intraoperative.The procedure was stopped and the patient was not treat but monitored.The patient is currently asymptomatic and no injury occurred.The anatomy was reported to have been tortuous.
Additional Manufacturer Narrative
The guidewire, the introducer needle and what appears to be hydrophilic coating material was returned for analysis.No issues were found with the returned guidewire introducer needle.The guidewire coating was found to be scrapped and missing from multiple locations along the guidewire.Per visual inspection, it appears that the coating is well adhered to the device.The coating material appears to have been torn by mechanical damage and does not look to be brittle or delaminated.The substrate layer of the coating has been completely removed leaving bare metal.The device will be sent out for additional testing.The guidewire distal tip was found to be bent.No other anomalies were observed.The investigation is still underway, upon completion a supplemental report will be submitted.Mdr related to this event: 2029214-2017-00290 2029214-2017-00291.
Additional Manufacturer Narrative
Based on the device analysis, sem results, the customer¿s reported information and video, the report of coating removal during use was confirmed, as the coating on the returned guidewire were found to be to be damaged.However, the cause for the reported event is likely to be use related.The coating layer was disrupted due to mechanical scraping of the wire surface by the introducer needle.No issues were found with the returned introducer needle.The remaining guidewire coating was found to be intact and well adhered to the wire surface with no evidence of delamination.From the provided video that the angle/position of the guidewire with relation to the introducer needle contributed to the mechanical scraping of the guidewire surface.The lot history record showed no discrepancies that would have contributed to the reported experience.All products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MIRAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6448101
• Report Number: 2029214-2017-00290
• Device Sequence Number: 10878234
• Product Code: DQX
• UDI-Device Identifier: 00847536004788
• UDI-Public: 00847536004788
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K002212
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/05/2017

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: 09/16/2018
• Device Model Number: 103-0608
• Device Lot Number: A174689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided; 07/05/2017; 07/05/2017; 07/05/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 05/09/2017; 07/10/2017; 10/02/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1