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

Model Number	BC0410C-ID
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2017
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.A lot history trending review was performed and there were no similar complaints for this lot number.The balloon was returned for evaluation.During the investigation, the balloon was inflated with saline, and a pinhole was found 1mm distal to the distal balloon marker band.The inflation plug and tight pitch coils remained underneath the polyimide ring.The investigation confirms the reported complaint of a pinhole rupture of the balloon.Based on the information provided, the balloon may have been damaged during manual pinching of the balloon during preparation.The instructions for use (ifu) cautions, "exercise care in handling the balloon catheter to reduce the chance of accidental damage.".
Event or Problem Description
It was reported that during the usual preparation process, the balloon was soaked.The balloon, however, was not inflated and deflated at that time, but was then manually "pinched" to achieve better tracking.During inflation of the balloon with contrast once the balloon had been placed in the patient, the balloon appeared to be ruptured.There was no reported patient injury or intervention.The patient was reported to be doing well.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X10 MM)
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7054859
• Report Number: 2032493-2017-00296
• Device Sequence Number: 13725878
• Product Code: MJN
• UDI-Device Identifier: 00842636020539
• UDI-Public: (01)00842636020539(11)170501(17)200430(10)1705011BN
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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: Other
• Device Expiration Date: 04/30/2020
• Device Model Number: BC0410C-ID
• Device Lot Number: 1705011BN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR