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

Model Number M00510880

Device Problems Separation Failure (2547); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).Although the suspect device has been received, the evaluation has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplement mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during a lithotripsy procedure performed on (b)(6) 2019.According to the complainant, after a mid-incision endoscopic sphincterotomy (est) was performed, a trapezoid basket was used to attempt to crush a 12 mm stone, but the stone could not be crushed and the tip of the basket failed to detach.The trapezoid sheath was cut with pliers, and an emergency lithotripter handle was used to attempt to retrieve the basket.However, the sheath could not be inserted into the emergency lithotripter and so the procedure was aborted.The patient underwent an operation to retrieve the basket.

Manufacturer Narrative

Block a2: exact patient age unknown, but reported to be in their 60's.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h2: blocks a3, b5, and h10 have been updated based on additional information received on november 10, 2019.Block h6: problem code 2547 captures the reportable event of tip failure to separate.Patient code 3191 addresses the required surgery.Block h10: visual inspection of the returned device found the thumb ring was detached and was not returned for analysis.The handle has coincident marks that indicate proper assembly during manufacturing process.Additionally, the device was returned cut in different sections and the coil stretched in several locations.The basket did not present any visual damage or abnormalities.The tip was intact and was still attached to the basket wires assembly.The basket tip joint strength was measured and found the basket was able to release the tip within specification.Based on all available information, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and integrity.Patient anatomy and user maneuvering to reach the intended locations can cause resistance during handle actuation and can lead to detachment of the thumbring from the handle.It's most likely that during use of the device the thumb ring could have received tensile and/or compressive force(s) applied parallel to the length of the device.Detachment of the thumb ring from the handle assembly can occur when force is applied perpendicular to the thumb ring/handle assembly, forcing the thumb ring out of the handle assembly.Therefore, the most probable root cause is adverse event related to procedure.A device history record (dhr) review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lot, and a dhr review on the most probable lot did not identify any deviations within manufacturing/service processes that could have contributed to the event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during a lithotripsy procedure performed on (b)(6) 2019.According to the complainant, after a mid-incision endoscopic sphincterotomy (est) was performed, a trapezoid basket was used to attempt to crush a 12mm stone, but the stone could not be crushed and the tip of the basket failed to detach.The trapezoid sheath was cut with pliers, and an emergency lithotripter handle was used to attempt to retrieve the basket.However, the sheath could not be inserted into the emergency lithotripter and so the procedure was aborted.The patient underwent an operation to retrieve the basket.The patient underwent an operation (surgery) to retrieve the basket on (b)(6) 2019.The patient condition after the operation was reported to be recovering.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9289847
• MDR Text Key: 165442799
• Report Number: 3005099803-2019-05404
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• 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
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 11/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention