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

Model Number	M00567380
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Initial reporter phone: (b)(6).(b)(4).Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned".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 common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, it was noted that the balloon would not inflate and was leaking.Reportedly, the device was removed from the bile duct to inspect endoscopically, and it was found that the balloon had at least 3 small hole leaks.The procedure was completed with another maxforce biliary dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block e1: initial reporter phone: (b)(6).Block h6: device code a041001 captures the reportable event of balloon pinholes.Block h10: investigation results a visual examination of the returned complaint device found that the balloon and the catheter did not have any visual defects and were in a good condition.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to one pinhole located at the distal section of the body of the balloon.Microscopic analysis was performed, and it was confirmed that the balloon had a pinhole.The reported event of balloon pinhole is therefore confirmed; however, the analysis did not confirm the reported presence of three or more pinholes.This failure is likely due to factors encountered during the procedure, such as the technique used by the physician and the interaction between the balloon with the scope during the procedure, could have created friction, causing the found failure of balloon pinhole.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.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 instruction for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, it was noted that the balloon would not inflate and was leaking.Reportedly, the device was removed from the bile duct to inspect endoscopically, and it was found that the balloon had at least 3 small hole leaks.The procedure was completed with another maxforce biliary dilatation balloon.There were 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: 11327901
• Report Number: 3005099803-2021-00452
• Device Sequence Number: 19111280
• Product Code: FGE
• UDI-Device Identifier: 08714729097075
• UDI-Public: 08714729097075
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K910931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: 12/03/2021
• Device Model Number: M00567380
• Device Catalogue Number: 6738
• Device Lot Number: 0023027609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1