MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC OCCLUSION BALLOON (4X11MM)

Model Number	BC0411XC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A search for non-conformances 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 has been returned to the manufacturer; the investigation is underway.
Event or Problem Description
It was reported that during an intracranial aneurysm, the balloon ruptured inside of the patient upon the first inflation attempt.There was no reported intervention, patient injury, or health damage.
Additional Manufacturer Narrative
The balloon was received for evaluation.A bypass device was used to get past the dried contrast in the catheter and the balloon was inflated, at which point a pinhole was observed at the distal balloon bond.The reported complaint is confirmed.The physical evaluation of the returned scepter xc found a pin hole on the balloon that aligns with the complaint description.The investigation could not confirm the circumstances that led to the pin-hole, but this condition is known to occur due to improper manipulation prior to or during the procedure or due to over inflation of the balloon.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X11MM)
• Common Device Name: BALLOON
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8848486
• Report Number: 2032493-2019-00183
• Device Sequence Number: 2548248
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)161104(17)191031(10)161104JC2
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2019

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: 10/31/2019
• Device Model Number: BC0411XC
• Device Catalogue Number: BC0411XC
• Device Lot Number: 161104JC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR