MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRAPEZOID¿ RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510860

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual analysis of the returned device found the side car-rx presented pushback out of specification.The evaluation concluded that during the procedure excessive manipulation of the device and interaction with the scope or other devices such as the guide wire most likely contributed to the side car-rx pushback.Therefore, the most probable root cause of this complaint is "operational context", since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.  the device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on an unknown date.According to the complainant, during the procedure, it was noted that the side car-rx (guidewire port) presented pushback making it difficult for the basket to get into the common bile duct.The procedure was completed with another trapezoid¿ rx basket.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 ¿stable".

• Brand Name: TRAPEZOID¿ RX
• 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: 7155933
• MDR Text Key: 96215747
• Report Number: 3005099803-2017-03838
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: 08714729296379
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2017

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 Expiration Date: 01/04/2018
• Device Model Number: M00510860
• Device Catalogue Number: 1086
• Device Lot Number: 20124320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2017
• 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