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

Model Number M00510880

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2017

Event Type  Injury  

Manufacturer Narrative

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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid¿ rx basket to crush a 11-12mm stone.However, the basket detached and remained inside the patient.Percutaneous surgery was performed on the same day to remove the basket with the entrapped stone.The patient¿s condition at the conclusion of the procedure was reported to be ¿okay¿.

Manufacturer Narrative

Additional information: user medwatch: mw5071303.Device was returned in three separated segments (handle, sheath, and basket).Visual analysis found the basket tip was intact and the side car-rx was torn at the proximal end.At the distal end of the heat shrink, the sheath was found torn and the working length kinked.Furthermore, the coil and pull wire was found broken at this section (proximal near the heat shrink).The sheath was buckled/accordion in several locations.The pull wire was also found broken from the distal tip, causing the basket section to be detached.The evaluation concluded that excessive manipulation of the device and interaction with the scope or other devices, the attempts to actuate the device, and the force applied to the device during the procedure could have affected its integrity.The failures are consistent with ones caused when excess force was applied to the product during its handling.Other factors like tortuosity of the patient anatomy can also affect the functionality of the product.Therefore, the most probable root cause is "operational context", since it is most likely that due to anatomical and/or procedural factors encountered during the procedure the performance of the device was limited.The evaluation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The device was designed for calculus larger than 1.5 cm.However, the device was used with the intention of retrieve a stone of over 11-12mm.The stone involved was smaller and the force applied could have been insufficient.Therefore, the most probable root cause is ¿user/use error¿.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed and found that the device was not used according to the dfu (directions for use).

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) 2017.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid¿ rx basket to crush a 11-12mm stone.However, the basket detached and remained inside the patient.Percutaneous surgery was performed on the same day to remove the basket with the entrapped stone.The patient¿s condition at the conclusion of the procedure was reported to be ¿okay¿.Additional information received as of 15aug2017 cholangiogram, cholecystectomy and common bile duct exploration was performed to remove the basket.A stent was then placed after the trapezoid basket was removed.The patient remains hospitalized three days post operation and is recovering.A jackson-pratt (jp) is placed for drainage and volume drained is diminishing.The patient appears to be ¿stable¿ after the surgical intervention.

• 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: 6771448
• MDR Text Key: 81956699
• Report Number: 3005099803-2017-02236
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: (01)08714729296393(17)20170927(10)19771228
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/27/2017
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 19771228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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 Outcome(s): Required Intervention