MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00533620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported to boston scientific corporation that a percuflex biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that the leading barb of the stent broke inside the patient.The piece of the broken stent was retrieved using a grasping forceps and the procedure was completed with another percuflex biliary stent.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 good.
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the proximal section of the stent damaged (ripped/torn) specifically the barb.Based on the product analysis, the issue could have been generated by excessive manipulation of the device by the user and/or excess of force applied to the product.The defect found is a known issue that is typically caused when the product has been pulled strongly until its breakage.Therefore, cause traced to component failure is selected as the most probable root cause for the complaint.A review of the device history record was performed and no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that the leading barb of the stent broke inside the patient.The piece of the broken stent was retrieved using a grasping forceps and the procedure was completed with another percuflex biliary stent.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 good.

• Brand Name: PERCUFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7872854
• Report Number: 3005099803-2018-60415
• Device Sequence Number: 16771109
• Product Code: FGE
• UDI-Device Identifier: 08714729181224
• UDI-Public: 08714729181224
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K834468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: M00533620
• Device Catalogue Number: 49655
• Device Lot Number: 0021996461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR