MAUDE Adverse Event Report: MICROVENTION INC. BALLOON CATHETER

Model Number	BC0410C-ID-700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device is reported available for return to the manufacturer for analysis.At this time the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies breakage/rupture potential complications associated with use of the device.
Event or Problem Description
It was reported that the distal marker detached from the tip of the balloon at the beginning of the embolization.The marker was removed without incident.No patient harm or injury was reported.
Additional Manufacturer Narrative
The investigation below is the evaluation/assessment of the physical device upon receipt.Items returned for investigation: scepter c items not returned for investigation: n/a inspection of the returned device found the distal tip to be separated.The broken distal tip did not exhibit any flattening; however, the proximal ends of the outer jacket of the separated distal tip did appear stretched at the location of the break, which indicates the device may have experienced a tensile break.The distal tip could not be recovered from the adhesive and gauze in which it was returned in and therefore, could not be further examined.The investigation of the returned balloon catheter found the distal tip to be separated, which is consistent with the alleged product issue.The proximal ends of the outer jacket of the separated distal tip appeared stretched, which indicates the device may have experienced a tensile break.The physical evaluation of the device could not identify the conditions or circumstances that led to the break, but a tensile break is consistent with the device experiencing retraction forces over specification.
Event or Problem Description
See h10.
Event or Problem Description
No additional information received.This report represents corrections to a previously submitted mdr.Fields corrected are listed.
Additional Manufacturer Narrative
Upon review of device registrations and mdrs submitted to the fda, discrepancies were noted.Clarification was received regarding the device registration and the following fields have been corrected: code correct, no change number correct, no change.The corrected information does not have any impact on the incident or investigative data submitted on earlier reports.The h6 codes and h11 investigation results stand as previously submitted.
Additional Manufacturer Narrative
A correction was made to section d2b product code.
Event or Problem Description
See h11 for correction.

• Brand Name: BALLOON CATHETER
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18360150
• Report Number: 2032493-2023-01132
• Device Sequence Number: 3981046
• Product Code: MJN
• UDI-Device Identifier: 00842429103388
• UDI-Public: (01)00842429103388(11)230422(17)260331(10)0000352035
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/24/2024
• 2 Devices were Involved in the Event: 1 2

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: 03/31/2026
• Device Model Number: BC0410C-ID-700
• Device Catalogue Number: BC0410C
• Device Lot Number: 0000352035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 03/26/2024; 06/11/2024; 06/24/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 04/23/2024; 06/21/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown