MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BACK-UP MEIER; WIRE, GUIDE, CATHETER

Model Number	41488
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: older than 18 years.Device evaluated by mfr.: the device was returned for analysis inside the hoop.Visual analysis revealed the spring tip was damaged.It was also observed that the core wire was detached from the welding ball.Inspection of the remainder of the device presented no other damages or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 24 apr 2019.It was reported that guidewire damage occurred.The target lesion was located in the abdominal aorta.A.035in, 300cm pta/meier guidewire was selected for use.However, during unpacking, it was noted that the device was stretched.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed the core wire was detached/separated.

• Brand Name: BACK-UP MEIER
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8605841
• Report Number: 2134265-2019-05150
• Device Sequence Number: 3029969
• Product Code: DQX
• UDI-Device Identifier: 08714729227908
• UDI-Public: 08714729227908
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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: 07/31/2020
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 22457385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 75