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

Model Number M00510890

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual evaluation of the returned device found the side car-rx presented pushback out of specification.A functional evaluation found the basket wires folded (twisted) and therefore failed to fully open.The basket wires were manually un-folded and the basket was found to be properly formed.The basket was then able to easily extend and retract.It is the most likely that during procedure the device could have been manipulated, since the failures side car-rx pushback and folded are issues that could have been generated by excessive manipulation of the device, the interaction with the scope or the interacting with other devices.Therefore, the most probable root cause of this complaint is operational context, since due to anatomical/procedural factors encountered during the procedure, performance was limited.The review of the device history record (dhr) was performed and no anomalies were found.A search of the database confirmed 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 performed on (b)(6) 2016.According to the complainant, during the procedure, the wires of the basket were found kinked after opening the package.The procedure was completed with another of the same device.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.This event has been deemed a reportable event based on the investigation results; side car-rx pushback.

• 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: 6152050
• MDR Text Key: 61736332
• Report Number: 3005099803-2016-03724
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: (01)08714729296409(17)20170112(10)18800849
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 11/17/2016

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: 01/12/2017
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 18800849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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
• Patient Age: 56 YR
• Patient Weight: 48