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

Model Number M00510880

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 08/04/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an trapezoid¿ rx was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the basket was used several times to remove stones, and when attempting to pull out a large stone, approximately ¿1 to 3cm¿ in size, the duodenum was perforated, and the patient went to surgery to address the perforation.Follow up was received on august 27, 2014 reporting that the elderly patient passed away due to unknown complications after the surgery.The complainant reported that the patient¿s death was not attributable to the device.There were no reported malfunction of the device.Note: the trapezoid¿ 3 x 6 basket is designed for crushing calculus larger than 1.5 cm (15 mm) in diameter.The stone may have been beyond the size mentioned in the dfu; they approximated that the stone was ¿1 to 3 cm.¿ reportedly, it was a ¿large stone.¿ the basket used in the procedure was 2.5 cm in diameter.

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.A visual and functional examination of the complaint device could not be performed since the device was not returned for analysis.A dhr (device history record) review was performed and no deviation was found.A labeling review was performed and no anomalies were found.The directions for use (dfu) list perforation as a possible complication, therefore, the most probable root cause classification is anticipated procedural complication.

• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4048693
• MDR Text Key: 4859391
• Report Number: 3005099803-2014-02960
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2014

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?: No
• Device Operator: Physician
• Device Expiration Date: 06/03/2015
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 17016633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2014
• 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
• Patient Age: 96 YR