MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PATHFINDER EXCHANGE GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number M00551590

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2016

Event Type  malfunction  

Event Description

Prior to beginning of ercp during inspection of devices - both doctor and staff noticed that the boston scientific pathfinder 0.018 cm x 450 cm (lot #185656644) appeared bent out, stretched out.Another package was opened, same product with lot #18575635 and also was identified prior to use as bent/stretched out.Doctor decided to use boston scientific hydrajagwire which had no defects and successfully completed ercp.

• Brand Name: PATHFINDER EXCHANGE GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5433427
• MDR Text Key: 38098237
• Report Number: 5433427
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2016,02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: M00551590
• Device Lot Number: 185656644
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2016
• Event Location: Other
• Date Report to Manufacturer: 02/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR