MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7492062009150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event : 18 years or older.(b)(4).Device evaluated by mfr.:returned product consisted of a maverick otw balloon catheter.The balloon was loosely folded with fluid in the balloon and lumen.The balloon, markerbands, inner/outer shaft, proximal bond were microscopically and tactile inspected.Inspection found no damage or irregularities or defects.Functional testing was done by attaching an inflation device (filled with water) to the hub of the maverick otw device and inflating the balloon to rated burst pressure (rbp).The device held rbp for 5 minutes; negative pressure was then applied to deflate the balloon.The balloon deflated per specifications.Inspection of the remainder of the device found no damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was reported that balloon deflation issue occurred.The target lesion was located in the mildly calcified vessel.A 9mm 1.50 maverick balloon catheter was advanced for dilation.However during deflation, it was noted that the balloon took some time to be fully deflated.The device was removed fully deflated and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6362769
• Report Number: 2134265-2017-01236
• Device Sequence Number: 13618968
• Product Code: LOX
• UDI-Device Identifier: 08714729260172
• UDI-Public: (01)08714729260172(17)20191031(10)0019897350
• Combination Product (Y/N): N
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2017

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: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: H7492062009150
• Device Catalogue Number: 20620-0915
• Device Lot Number: 0019897350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1