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

Model Number	M00567370
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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
Note: this report pertains to one of two maxforce biliary balloons used in the same patient and procedure.It was reported to boston scientific corporation that two maxforce biliary dilation balloons were used during a biliary dilation procedure performed on an unknown date.According to the complainant, during preparation, both balloons would not inflate due to small holes.Reportedly, the devices were removed and the procedure was completed with another maxforce biliary dilation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• 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: 9516301
• Report Number: 3005099803-2019-06193
• Device Sequence Number: 3096069
• Product Code: FGE
• UDI-Device Identifier: 08714729097068
• UDI-Public: 08714729097068
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/24/2019

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: 09/10/2021
• Device Model Number: M00567370
• Device Catalogue Number: 6737
• Device Lot Number: 0022636695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1