MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number UNK213

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx lithotripter compatable basket was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during the ercp, a guidewire and sphincterotome (unknown upns) were used before the trapezoid¿ rx lithotripter compatable basket with no issues.There was no visible damage to the trapezoid¿ rx lithotripter compatable basket or its packaging prior to use.The trapezoid¿ rx lithotripter compatable basket was the next device to be used during the ercp.The basket was inserted in the patient, and when attempting to open the basket inside the patient a cracking sound was heard at the handle and the basket failed to open.The device was removed from the patient and a suture like material was seen at the distal tip.The tip was intact and no part of the device had detached inside the patient.The plastic stent was placed to complete the procedure.A spyglass procedure is scheduled to locate the stone.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Reportedly, the suture like material did not come from the guidewire and sphincterotome used prior to the trapezoid¿ rx lithotripter compatable basket.It is unknown exactly where the suture came from.

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

• Brand Name: TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4387895
• MDR Text Key: 14880291
• Report Number: 3005099803-2014-04144
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2014

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: Physician
• Device Model Number: UNK213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1