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 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4): although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a removal of bile duct stone procedure on (b)(6), 2015.According to the complainant, during the procedure, endoscopic sphincterotomy (est) was performed.Thereafter, using a trapezoid rx basket, the physician removed a stone from the common bile duct and into the doudenum.An attempt to reinsert the device into the common bile duct was made, however, the side car-rx presented push back and there was difficulty advancing the device over the guidewire.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 "good".

Manufacturer Narrative

A visual evaluation of the device found the side car-rx to present pushback out of specification and was torn at the proximal end.Furthermore, the sheath was buckled adjacent to the heat shrink.A functional evaluation was performed by inserting a.035" guidewire through the side car-rx without any resistance.The side car-rx compression and pushback could cause difficulty in tracking the device over the guidewire and into the papilla.Per the event info the issue was noticed during the procedure and while inside the patient.Due to anatomical /procedural factors encountered during the procedure performance was limited.Therefore, the most probable root cause for this complaint is operational context.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 a removal of bile duct stone procedure on (b)(6) 2015.According to the complainant, during the procedure, endoscopic sphincterotomy (est) was performed.Thereafter, using a trapezoid ¿ rx basket, the physician removed a stone from the common bile duct and into the duodenum.An attempt to reinsert the device into the common bile duct was made, however, the side car-rx presented push back and there was difficulty advancing the device over the guidewire.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 "good.".

• 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: 5323440
• MDR Text Key: 34273916
• Report Number: 3005099803-2015-03656
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• 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,Followup
• Report Date: 12/01/2015

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: 09/20/2016
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 18425363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• 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