MAUDE Adverse Event Report: BOSTON SCIENTIFIC TRAPEZOID RX 2.5CM; BASKET RETRIEVAL CATHETER

Model Number M00510880

Device Problem Peeled/Delaminated (1454)

Patient Problem No Information (3190)

Event Date 12/21/2017

Event Type  malfunction  

Event Description

Boston scientific trapezoid rx 2.5 cm retrieval basket, plastic sheath covering metal part of device noted to be peeing off when removed from scope.No defects noted prior to insertion into scope.

• Brand Name: TRAPEZOID RX 2.5CM
• Type of Device: BASKET RETRIEVAL CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 7147728
• MDR Text Key: 95954445
• Report Number: MW5074253
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2017

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
• Device Operator: Health Professional
• Device Model Number: M00510880
• Device Catalogue Number: M00510880
• Device Lot Number: 20354491
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1