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

Model Number BC0420C-ID-700

Device Problems Deflation Problem (1149); Particulates (1451)

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

Event Date 02/09/2023

Event Type  malfunction  

Event Description

It was reported that the scepter balloon appeared deformed after inflation.The physician was unable to deflate the balloon and it had to be removed inflated, which worked without any issues.The balloon was visually investigated after removal, and some black particles came out of the lumen of the balloon.There was no patient injury reported, and the event had no influence on patient¿s outcome.

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination could not be performed as this information was not available or provided at the time this.The device was reported to be available for return to the manufacturer for evaluation, but has not yet been returned; however, radiographic images were provided and reviewed.The inability to deflate the balloon and particles could not be confirmed through device investigation at this time.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The following is the investigation conclusion written prior to the return and physical evaluation of the device.Two radiographic images were submitted.None of the images were labeled as to date, time, location artery imaged.Image 1 is a subtracted roadmap image with no contrast.There are coils, presumably in a medium sized aneurysm; the coil ball is about 3x the diameter of the inflated balloon.The balloon is inflated across the neck of the aneurysm/coils but exhibits an abnormal appearance, the same as seen in the customer submitted photographs of the device after it was removed from the patient.There is a proximal short round inflated segment followed by the usual sausage appearance of the normal scepter balloon.Image 2 is a subtracted roadmap image with no contrast; different projection compared to the previous image.There are coils, presumably in a medium sized aneurysm; the coil ball is about 3x the diameter of the inflated balloon.The balloon is inflated across the neck of the aneurysm/coils but exhibits an abnormal appearance, the same as seen in the customer-submitted photographs of the device after it was removed from the patient.There is a proximal short round inflated segment followed by the usual sausage appearance of the normal scepter balloon.Two additional images showing the physical device are received and supplement the procedural images; these images show the condition as described in the reported event.The reason for the abnormal inflation pattern of the balloon is not demonstrated on or explained by these images.

Manufacturer Narrative

Two of four radiographic images review found that none are labeled as to date, time, location/artery imaged.Image 1 is a subtracted roadmap image, no contrast.There are coils, presumably in a medium-sized aneurysm (the coil ball is about 3x the diameter of the inflated balloon).The balloon is inflated across the neck of the aneurysm/coils but exhibits an abnormal appearance, the same as seen in the customer-submitted photographs of the device after it was removed from the patient.There is a proximal short round inflated segment followed by the usual ¿sausage¿ appearance of the normal scepter balloon.Image 2 is a subtracted roadmap image, no contrast ¿ different projection compared to the previous image.There are coils, presumably in a medium-sized aneurysm (the coil ball is about 3x the diameter of the inflated balloon).The balloon is inflated across the neck of the aneurysm/coils but exhibits an abnormal appearance, the same as seen in the two additional customer-submitted photographs (image 3 and image 4) of the device after it was removed from the patient.There is a proximal short round inflated segment followed by the usual ¿sausage¿ appearance of the normal scepter balloon.The reason for the abnormal inflation pattern of the balloon is not demonstrated on or explained by these images.The investigation of the returned balloon catheter found damaged coils and the polyimide ring dislodged at the proximal end of the balloon; furthermore, the balloon was found with an abnormal bulbous shape at the proximal end during inflation testing.The coil damage and displaced polyimide ring appeared to create an increased outer diameter at that proximal end of the balloon, which resulted in the abnormal shape of the inflated balloon.The investigation of the balloon lumen and the returned syringe did not identify any ¿black particulate¿ as described in the reported event.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 due to over inflation.

Event Description

Please see h10 for device investigation conclusion.

• Brand Name: SCEPTER C OCCLUSION BALLOON
• Type of Device: OCCLUSION 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: 16464760
• MDR Text Key: 310493644
• Report Number: 2032493-2023-00589
• Device Sequence Number: 1
• Product Code: DQY
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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: BC0420C-ID-700
• Device Catalogue Number: BC0420C
• Device Lot Number: 0000092462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female