MAUDE Adverse Event Report: MICROVENTION SCEPTER C; SCEPTER C OCCLUSION BALLOON CATHETER

Model Number BC0410C

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2022

Event Type  malfunction  

Event Description

During the procedure, a scepter balloon was used to angioplasty a pipleline shield that would not open.After inflating the balloon, it would not deflate.The balloon was removed from the patient partially inflated.There was no patient injury or intervention reported.Patient condition is unknown.Additional information was received stating the balloon was observed to be normal during preparation.The inflation pressure of the balloon is unknown.The balloon was partially deflated by aspiration with 1cc syringe.The device was removed by aspiration and retrieval through the wahoo guide catheter.There was blood inside the balloon lumen once it was retrieved.

Manufacturer Narrative

A search for non-conformance associated with this 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 evaluation but has not yet been returned.If the device is received the investigation will be performed and a supplemental report will be submitted.

Manufacturer Narrative

G4 correction: not a combination product.

Manufacturer Narrative

Correction for investigation results copied twice.The inspection of the returned device found the shaft to be severely crushed, affecting the inflating and deflating lumen of the device.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.A review of the manufacturing records found that this lot met all release criteria from the manufacturing procedure.

Manufacturer Narrative

The inspection of the returned device found the shaft to be severely crushed, affecting the inflating and deflating lumen of the device.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.A review of the manufacturing records found that this lot met all release criteria from the manufacturing procedure.The inspection of the returned device found the shaft to be severely crushed, affecting the inflating and deflating lumen of the device.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.A review of the manufacturing records found that this lot met all release criteria from the manufacturing procedure.

Event Description

Additional information provided confirmed the patient is doing well.The patient didn't receive any kind of treatment and didn't have any negative impact.

• Brand Name: SCEPTER C
• Type of Device: SCEPTER C OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 14579841
• MDR Text Key: 293285509
• Report Number: 2032493-2022-00184
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00842429103388
• UDI-Public: (01)00842429103388(11)210915(17)240831(10)0000080247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/15/2022

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
• Device Operator: Health Professional
• Device Model Number: BC0410C
• Device Catalogue Number: BC0410C
• Device Lot Number: 0000080247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 04/15/2022; 04/15/2022; 04/15/2022; 04/15/2022
• Supplement Dates FDA Received: 07/07/2022; 07/13/2022; 07/14/2022; 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR