MAUDE Adverse Event Report: MICROVENTION, INC SCEPTER C OCCLUSION BALLOON;(4X10 MM); OCCLUSION BALLOON CATHETER

Model Number	BC0410C-ID-700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance's 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 was stated to be available for analysis but has not yet been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device is received, the investigation will be performed, and a supplemental report will be submitted.The instruction for use (ifu) include the warnings: do not exceed the maximum recommended inflation volume as balloon rupture may occur.Excessive pressure higher than 300 psi (2069kpa) may cause leakage or rupture of the balloon catheter working lumen.
Event or Problem Description
It was reported that during the procedure, a scepter c balloon ruptured during inflation.There was no reported intervention or injury to the patient.
Additional Manufacturer Narrative
Additional information: d9 (date device received).Additional information was received indicating the balloon leak was a slow one.No adverse patient effects from this complaint.Summary device evaluation: the inspection of the returned scepter c found a pinhole when inflated near the proximal bond of the balloon.The investigation could not determine what likely caused the pinhole as no other contributing factors or conditions were found during this evaluation; a review of the manufacturing records found that this lot met all release criteria from the manufacturing procedure.

• Brand Name: SCEPTER C OCCLUSION BALLOON;(4X10 MM)
• Common Device Name: OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise dr.; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14401772
• Report Number: 2032493-2022-00197
• Device Sequence Number: 17515396
• Product Code: MJN
• UDI-Device Identifier: 00842429103388
• UDI-Public: (01)00842429103388(11)210831(17)240731(10)0000070322
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110741
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 07/31/2024
• Device Model Number: BC0410C-ID-700
• Device Catalogue Number: BC0410C
• Device Lot Number: 0000070322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown