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 01/08/2016

Event Type  Injury  

Manufacturer Narrative

Reported event of tip detached prematurely.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 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) with stone extraction procedure on (b)(6) 2016.According to the complainant, the patient was scheduled for esophagogastroduodenoscopy (egd), endoscopic ultrasound (eus), and endoscopic retrograde cholangiopancreatogram (ercp).During ercp procedure, while attempting to extract common bile duct (cbd) stone the basket tip detached prematurely.The physician stated that she felt the staff may have closed the handle quickly causing the tip to detach.The physician used an extractor balloon to sweep the stone and the tip out of the common bile duct.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ¿fine.".

Manufacturer Narrative

Visual analysis of the device found the basket wires retracted; and the tip was detached and not returned.Further evaluation found the proximal end of the side car-rx was torn away from the coil assembly.Evaluation concluded that the condition of the return device was consistent with the complaint incident that the tip of the basket detached prematurely.Per the event information, the most probable root cause for this complaint is "operational context." the device history record (dhr) review found that 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

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) with stone extraction procedure on (b)(6) 2016.According to the complainant, the patient was scheduled for esophagogastroduodenoscopy (egd), endoscopic ultrasound (eus), and endoscopic retrograde cholangiopancreatogram (ercp).During ercp procedure, while attempting to extract common bile duct (cbd) stone the basket tip detached prematurely.The physician stated that she felt the staff may have closed the handle quickly causing the tip to detach.The physician used an extractor balloon to sweep the stone and the tip out of the common bile duct.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "fine.".

• 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: 5456397
• MDR Text Key: 38865600
• Report Number: 3005099803-2016-00206
• 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: 01/25/2016

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: 07/12/2016
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 18187825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• 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
• Patient Outcome(s): Required Intervention