MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X15 MM); BALLOON CATHETER

Model Number	BC0415C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The device has been returned for evaluation.The investigation is currently ongoing.
Event or Problem Description
It was reported that the balloon "broke" during the inflation.The balloon was replaced with a new scepter c balloon.There was no reported patient injury.The patient is reported to be "fine.".
Additional Manufacturer Narrative
The device was received for evaluation.The balloon was noted to be returned with a large linear tear.The inflation plug and close-pitch coils were not enclosed within the polyimide.The de-airing channel and purge hole were present, and in the correct position based on the investigation and provided information, the complaint can be confirmed.The device exhibits evidence of overinflation of the balloon material.The instructions for use (ifu) warns, "do not exceed the maximum recommended inflation volume as balloon rupture may occur.".

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X15 MM)
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6445079
• Report Number: 2032493-2017-00076
• Device Sequence Number: 19003288
• Product Code: MJN
• UDI-Device Identifier: 00810170015816
• UDI-Public: (01)00810170015816(11)160114(17)190114(10)16011434
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2017

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: Physician
• Device Expiration Date: 01/14/2019
• Device Model Number: BC0415C
• Device Lot Number: 16011434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR