MAUDE Adverse Event Report: MICROVENTION, INC SCEPTER C; PERCUTANEOUS CATHETER

Model Number	BC0415C-ID-700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
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 scepter c balloon catheter was found to be leaking.Multiple kinks and deformation were found at multiple locations.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
It was reported that during balloon inflation within a flow diverter stent, the balloon rapidly lost pressure.The balloon catheter was removed in its entirety from the patient.There was no patient injury.

• Brand Name: SCEPTER C
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 12298386
• Report Number: 2032493-2021-00316
• Device Sequence Number: 3180894
• Product Code: DQY
• UDI-Device Identifier: 00842429103395
• UDI-Public: (01)00842429103395(11)200708(17)230630(10)20070811B
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: 06/30/2023
• Device Model Number: BC0415C-ID-700
• Device Lot Number: 20070811B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 60