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

Model Number M00510870

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.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.A second physician was also reported during the case.Physician's name is (b)(6).

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2016-00042 for the first trapezoid rx basket and manufacturer report# 3005099803-2016-00047 for the second trapezoid rx basket.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) 2015.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush an 8mm size stone.The stone was unable to be crushed.The handle and the sheath were cut and removed from the patient leaving a single wire hanging from the patient¿s mouth.A sohendra device was used in an attempt to detach the tip; however the tip failed to detach.A second physician then assisted with the case using a hurricane balloon to dilate the common bile duct, and was able to wiggle the stone from the basket.The hurricane balloon was removed from the patient, and the trapezoid¿ rx basket was able to be removed from the patient.The physician then used a second trapezoid basket in conjunction with an alliance handle, to try to crush the stone.The basket of the second trapezoid¿ rx basket detached inside the patient with 2 cm wire hanging out of the ampulla in the duodenum.The physician placed 2 pigtail biliary stents for drainage, and the basket and stone remained inside the patient.The patient was discharged, and a planned procedure was scheduled to remove the detached basket and stents, and laser the stone.On (b)(6) 2016, the stents were removed, and the basket was noted to have passed.Fluoroscopy and ct scan confirmed that the basket was no longer inside the patient.The procedure was successfully completed.The patient's current condition was reported to be ¿stable.¿.

Manufacturer Narrative

A visual examination found the device received with the basket, however the tip was detached and not returned.Further evaluation revealed that the side car-rx presented pushback out of specification.The coil assembly/outer sheath was torn and buckled.Evaluation of the basket found the wires complete and unbroken.Evaluation concluded that the condition of the returned unit was not consistent with the complaint incident that the basket detached.It appears the basket tip detached during use and the customer mistook the separated tip as a detached basket.Therefore, the reported event of basket detached is "not confirmed".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.A labeling review was performed and there is not enough information to determine that the device was not used in accordance with the labeling.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2016-00042 for the first trapezoid rx basket and manufacturer report# 3005099803-2016-00047 for the second trapezoid rx basket.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) 2015.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush an 8mm size stone.The stone was unable to be crushed.The handle and the sheath were cut and removed from the patient leaving a single wire hanging from the patient's mouth.A sohendra device was used in an attempt to detach the tip; however the tip failed to detach.A second physician then assisted with the case using a hurricane balloon to dilate the common bile duct, and was able to wiggle the stone from the basket.The hurricane balloon was removed from the patient, and the trapezoid rx basket was able to be removed from the patient.The physician then used a second trapezoid basket in conjunction with an alliance handle, to try to crush the stone.The basket of the second trapezoid rx basket detached inside the patient with 2 cm wire hanging out of the ampulla in the duodenum.The physician placed 2 pigtail biliary stents for drainage, and the basket and stone remained inside the patient.The patient was discharged, and a planned procedure was scheduled to remove the detached basket and stents, and laser the stone.On (b)(6) 2016, the stents were removed, and the basket was noted to have passed.Fluoroscopy and ct scan confirmed that the basket was no longer inside the patient.The procedure was successfully completed.The patient's current condition was reported to be "stable".

• 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: 5384699
• MDR Text Key: 36583838
• Report Number: 3005099803-2016-00047
• Device Sequence Number: 1
• Product Code: LQC
• 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,Followup
• Report Date: 12/28/2015

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: Health Professional
• Device Expiration Date: 10/16/2016
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 18524811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• 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