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

Model Number M00510880

Device Problem Separation Failure (2547)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); No Information (3190)

Event Date 06/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental 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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a basket was used in an attempt to crush a 1cm stone.However, the handle of the basket lost its tension, and the basket failed to crush the stone or to release the tip of the basket.A sohoendra device was then used in an attempt to detach the tip of the basket in order to release the stone, but this also failed.The scope was then removed, and the basket was left inside the patient.On (b)(6) 2019, the patient was transported to another facility for a follow-up ercp.The remaining basket and stone were removed.The patient experienced bleeding post-procedure and was admitted for a blood transfusion.The patient was then discharged but went back to the emergency room for right-side and shoulder pain.A large hematoma was found in her liver.The patient underwent a cholecystectomy procedure for repeat stones, and an external drain was placed for the hematoma.In the physician's assessment, the removal of the basket in the follow-up ercp caused or contributed to the bleeding and liver hematoma.The patient's condition's is now reportedly 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: 8818414
• MDR Text Key: 151945501
• Report Number: 3005099803-2019-03701
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0023077997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2018
• 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 Outcome(s): Hospitalization; Required Intervention