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

Model Number	M0061752730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Problem code captures the reportable event of guide catheter broke.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 or Problem Description
It was reported to boston scientific corporation that a percuflex plus stent was to be used in a procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that the stent was half section by the wire.The percuflex plus stent was not used in a patient, nor was it involved in a procedure.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus stent was to be used in a procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that the stent was half section by the wire.The percuflex plus stent was not used in a patient, nor was it involved in a procedure.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
A percuflex plus stent was received for evaluation.A visual evaluation revealed that the bladder pigtail was found torn, the torn section is specifically located in a sideport hole.The suture string was not returned for evaluation.No other anomalies or damages were encountered.Based on the product analysis, the defect noted of tear in the stent could have been caused by the user due to excessive manipulation of the stent or the interaction with other devices during the unpacking or the preparation.Therefore, a conclusion code of "cause traced to component failure" was assigned to this complaint since expected or random component failure without any design or manufacturing issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7967029
• Report Number: 3005099803-2018-60871
• Device Sequence Number: 16581200
• Product Code: FAD
• UDI-Device Identifier: 08714729041207
• UDI-Public: 08714729041207
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K924608
• 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): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2021
• Device Model Number: M0061752730
• Device Catalogue Number: 64135
• Device Lot Number: 0021789819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1