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

Model Number	M00536630
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the dece was not used past its expiry.(b)(4).(b)(6).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 pancreatic stent was used during a procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was found that the tip of the advanix pancreatic stent was kinked.The procedure was completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).(b)(6) 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 an advanix pancreatic stent was used during a procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was found that the tip of the advanix pancreatic stent was kinked.The procedure was completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during a procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was found that the tip of the advanix pancreatic stent was kinked.The procedure was completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 2976 captures the reportable event of stent kinked.Block e1: initial facility address: (b)(6) hospital.Block h10: investigation analysis: a visual evaluation of the returned pancreatic stent found that the stent was free of free kinks and bends.Burrs were visible on the distal tip.The flash/burr was measured with a tappi chart and it was greater than 0.20 mm which is out of specification; consequently, confirming the reported complaint 'tip of the advanix pancreatic stent was found to be lifted'.Based on the product analysis, it was determined that the flash/burr was greater than 0.20 mm and as per procedure 90554509 ver.Ag (cosmetic inspection procedure), surface irregularity: flash/die & parting lines/burr/gels is allowable up to 0.20 mm, therefore the defect found was out of specification.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as "quality control deficiency" since problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself, ncep-00094049 addressed the issue of flash or burr at the tip of stent.Therefore, it was concluded that the investigation conclusion code of this event is 'quality control deficiency' since the problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself, ncep-00094049 addressed the issue of flash or burr at the tip of stent.Dhr review was performed and no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8491390
• Report Number: 3005099803-2019-01652
• Device Sequence Number: 11157021
• Product Code: FGE
• UDI-Device Identifier: 08714729857570
• UDI-Public: 08714729857570
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• 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,Followup
• Report Date (Section B): 07/01/2019

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: 06/05/2021
• Device Model Number: M00536630
• Device Catalogue Number: 3663
• Device Lot Number: 0022212528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/30/2019; 06/06/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/23/2019; 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1