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

Model Number	M00567420
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 a maxforce biliary dilatation balloon was used in the duodenum near the papilla and common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure of a product development in vivo porcine animal lab trial on (b)(6) 2019.According to the complainant, upon withdrawal, it was noticed that the balloon was not deflating with use of the inflation device.Reportedly, the device was attempted to be removed prior to fully deflating; however, it could not be pulled out of the scope due to the balloon bunching up.It was also noted that the guidewire could not be removed due to the damage.The duodenum was extubated from porcine mouth, and the distal tip of the device was cut to be removed from the duodenoscope.The procedure was completed at this time.As this occurred during a porcine lab, there was no patient involved.
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device found that shaft was kinked and stretched.The balloon portion of the device had been cut off and was not returned.Functional evaluation was performed and found that the jagwire was in the balloon device but was unable to be removed due to the balloon shaft being stretched and kinked.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.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 a maxforce biliary dilatation balloon was used in the duodenum near the papilla and common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure of a product development in vivo porcine animal lab trial on (b)(6) 2019.According to the complainant, upon withdrawal, it was noticed that the balloon was not deflating with use of the inflation device.Reportedly, the device was attempted to be removed prior to fully deflating; however, it could not be pulled out of the scope due to the balloon bunching up.It was also noted that the guidewire could not be removed due to the damage.The duodenum was extubated from porcine mouth, and the distal tip of the device was cut to be removed from the duodenoscope.The procedure was completed at this time.As this occurred during a porcine lab, there was no patient involved.

• Brand Name: MAXFORCE
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9249169
• Report Number: 3005099803-2019-05108
• Device Sequence Number: 14044183
• Product Code: FGE
• UDI-Device Identifier: 08714729097099
• UDI-Public: 08714729097099
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K910931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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: 04/10/2022
• Device Model Number: M00567420
• Device Catalogue Number: 6742
• Device Lot Number: 0023629343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1