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

Model Number	M00534280
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: (b)(6).(b)(4).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 an advanix-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2020.According to the complainant, during unpacking, it was noticed that a hairlike foreign matter was present inside the sterile bag.Another advanix-naviflex biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be good.A photo of the complaint device was provided and showed that a hairlike foreign matter was present inside the sterile bag.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6) block h6: device code 2969 captures the reportable event of device contaminated during manufacture or shipping.Block h10: an advanix rx biliary stent was returned in its unopened pouch and a visual evaluation noted that a hair was inside the sealed pouch.No other issues with the device were noted.The reported event was confirmed.During visual and media assessment, it was observed hair inside the sealed pouch, resulting in the report complaint issue of packaging foreign matter.Therefore, 'manufacturing deficiency' is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6), 2020.According to the complainant, during unpacking, it was noticed that a hairlike foreign matter was present inside the sterile bag.Another advanix-naviflex biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be good.A photo of the complaint device was provided and showed that a hairlike foreign matter was present inside the sterile bag.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10021546
• Report Number: 3005099803-2020-01724
• Device Sequence Number: 11441766
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: 08714729787372
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101314
• 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): 06/22/2020

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: 11/14/2020
• Device Model Number: M00534280
• Device Catalogue Number: 3428
• Device Lot Number: 0022946592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1