MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X15MM); OCCLUSION BALLOON CATHETER

Model Number	BC0415C
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record 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 catheter was returned for analysis.Visual inspection confirmed the balloon was returned deflated, and dried contrast was observed inside the balloon.The balloon was then inflated with saline, and high resistance was felt when inflating and deflating the balloon.High concentration of contrast solution was observed inside the balloon.After diluting the contrast solution inside the balloon with saline, no resistance was encountered and the balloon was able to inflate and deflate, and operated within specification.Based upon investigation findings and available information, resistance was encountered during initial testing; however, after diluting the contrast solution, the balloon catheter functioned normally and within specification.The reported issue was caused by improper use of contrast solution.
Event or Problem Description
It was reported that a stent was implanted in the internal carotid artery and the scepter balloon was inflated to post-dilate the stent; however, the balloon could not be deflated.Attempts to deflate the balloon with a 3ml and a 20ml syringe were unsuccessful and the inflated balloon was removed through the stent.There was no movement of the stent from its implanted position during the balloon retraction.There was no reported patient injury or procedural clinical consequence, and no intra-procedural medications were given to the patient outside of normal procedure protocol at the time of the event or post-procedure.The patient was reported to be doing well.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X15MM)
• Common Device Name: OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8541751
• Report Number: 2032493-2019-00101
• Device Sequence Number: 18924295
• Product Code: MJN
• UDI-Device Identifier: 00842636020546
• UDI-Public: (01)00842636020546(11)180613(17)210531(10)18061353Z
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/25/2019

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: 05/31/2021
• Device Model Number: BC0415C
• Device Catalogue Number: BC0415C
• Device Lot Number: 18061353Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR