MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510890

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the dealer.The physician present for this case was: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, a trapezoid basket was used in an attempt to manually crush a stone.However, the handle cannula was kinked.With the stone still inside the basket, the physician pulled the catheter and managed to pull the basket out.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 following the procedure was reported to be stable.

Manufacturer Narrative

Block e1: this event was reported by the dealer.The physician present for this case was: dr.(b)(6).Block e1: initial reporter facility name: (b)(6).Block h6: device code a04069 captures the reportable event of handle cannula bent.Block h10: the return trapezoid rx basket was analyzed, and a visual evaluation noted that the plastic handle was detached from the working length.The hypotube was broken and kinked at the proximal section.The handle shows evidence of over manipulation, like cracks and the heat shrink cut off.The working length shows sheath buckled, coil exposed, and the side car push back.Microscope inspection of the broken hypotube shows marks of rough breakage.The screws does not show position or depth issues.No other issues were noted.The reported event was confirmed.Based on all available information, it is possible that the manipulation or the technique used in conjunction with an excess force could have kinked the handle.The evidence found suggest that there might have been difficulty during the procedure that has resulted in the need to cut off the handle as indicated in the "directions for use/emergency precautions".Probably when force have been applied to the handle, the hypotube was kinked, causing difficulty to be activated.The manipulation in that condition could break the hypotube since there is evidence of a rough breakage and the inspection revealed that the handle was assembled correctly.After it broke, it is necessary to cut off the heat shrink.The over manipulation of the unit caused the cracks in the handle.To remove the device, it could have been pulled in such a way that stretched and exposed the coil, buckling the sheath, and side car push back.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, a trapezoid basket was used in an attempt to manually crush a stone.However, the handle cannula was kinked.With the stone still inside the basket, the physician pulled the catheter and managed to pull the basket out.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 following the procedure was reported to be stable.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12930027
• MDR Text Key: 286868107
• Report Number: 3005099803-2021-06323
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0026900938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 78 KG