MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493892812250
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The balloon was loosely folded with fluid in the balloon and lumen.The hypotube, distal shaft, balloon, markerbands, and tip were microscopically and tactile inspected.Inspection revealed a burst in the balloon material that was 8 mm in length and numerous kinks in the hypotube.Inspection of the remainder of the device revealed no other damage or irregularities.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
Reportable based on analysis completed on 04-oct-2017.It was reported that shaft kink occurred.Vascular access was obtained via the femoral artery.The 24x3.0mm, de novo target lesion was located in the none tortuous and severely calcified left circumflex (lcx) artery.A 2.50mm x 12mm maverick²¿ balloon catheter advanced for dilatation.However, during the procedure, it was noted that the balloon shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, returned device analysis revealed balloon torn longitudinally.

• Brand Name: MAVERICK²¿
• 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: 6975070
• Report Number: 2134265-2017-10296
• Device Sequence Number: 518319
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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: 05/07/2020
• Device Model Number: H7493892812250
• Device Catalogue Number: 38928-1225
• Device Lot Number: 20617342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1