MAUDE Adverse Event Report: BOSTON SCIENTIFIC TRAPEZOID RX WIREGUIDED ; LITHOTRIPTOR

Model Number 08714729296386

Device Problems Break (1069); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 09/18/2017

Event Type  malfunction  

Event Description

When doing an endoscopic retrograde cholangio-pancreatography (ercp), the gastroenterologist requested a wire-guided retrieval basket from the staff.A new package was opened and given to the physician.Before placing it into the endoscope and patient, he noticed that at the tip of the instrument, the sheath was torn and the basket was broken.It was removed from the surgical field and another one package was open that had a working retrieval basket.

• Brand Name: TRAPEZOID RX WIREGUIDED
• Type of Device: LITHOTRIPTOR
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 6906768
• MDR Text Key: 88032164
• Report Number: MW5072552
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 9057057301
• UDI-Public: 90570573-01
• 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: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2018
• Device Model Number: 08714729296386
• Device Catalogue Number: M00510870
• Device Lot Number: 20977961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2017
• 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