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

Model Number	M00567420
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
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 maxforce biliary dilatation balloon was used during a endoscopic papillary dilation procedure performed in the bile duct and papilla on (b)(6) 2020.According to the complainant, during the procedure, the balloon was attempted to be inflated; however, there was severe resistance and difficulty in injecting the contrast media into the balloon.The balloon was then deflated, and another attempt was made to inflate the balloon in the papilla.After the dilation it was noted that the balloon could not be deflated.The inflation device was disconnected from the device, and a syringe was used to attempt to deflate the balloon, but it could still not be deflated.The balloon was then removed from the patient together with the endoscope, and the balloon was pierced with a needle in order to be deflated.The procedure was completed at this time.There have been no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 1149 captures the reportable event of balloon failed to deflate.Block h10: investigation results a visual examination of the returned complaint device found that the balloon did not have any visual defects and was in a good condition.The catheter was noted to be stretched in different sections.Functional analysis was attempted to be performed; however, the balloon lumen was occluded and could not be unblocked.Based on the available information, it is possible that factors encountered during the procedure, the interaction between the scope and the balloon the anatomy of the patient, and/or the quantity the force applied during the insertion/removal could have resulted in the balloon not being able to inflate or deflate correctly.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.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used during a endoscopic papillary dilation procedure performed in the bile duct and papilla on (b)(6) 2020.According to the complainant, during the procedure, the balloon was attempted to be inflated; however, there was severe resistance and difficulty in injecting the contrast media into the balloon.The balloon was then deflated, and another attempt was made to inflate the balloon in the papilla.After the dilation it was noted that the balloon could not be deflated.The inflation device was disconnected from the device, and a syringe was used to attempt to deflate the balloon, but it could still not be deflated.The balloon was then removed from the patient together with the endoscope, and the balloon was pierced with a needle in order to be deflated.The procedure was completed at this time.There have been no patient complications reported as a result of this event.

• 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: 9701485
• Report Number: 3005099803-2020-00339
• Device Sequence Number: 1810787
• Product Code: FGE
• UDI-Device Identifier: 08714729097099
• UDI-Public: 08714729097099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910931
• 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): 03/30/2020

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: 03/04/2021
• Device Model Number: M00567420
• Device Catalogue Number: 6742
• Device Lot Number: 0021817062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1