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

Model Number	H7493892812250
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The shafts, balloon and tip were microscopically and visually examined.There was blood in the inflation lumen, guidewire lumen and balloon.The balloon was loosely folded.Microscopic examination of the balloon revealed that there was a 9mm longitudinal tear at the proximal end of the balloon.Microscopic examination presented no irregularities in the balloon material or the markerband that could have contributed to the damage.Inspection of the remainder of the device revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 01-oct-2018.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 32 x 4mm, de novo target lesion was located in the tortuous and severely calcified left anterior descending artery.A 2.50mm x 12mm maverick²¿ balloon catheter was advanced for pre-dilatation.However, the device failed to cross the lesion.Subsequently, pre-dilatation was performed with a non-bsc balloon catheter followed by stenting and the procedure was completed.No patient complications were reported and the patient's status was good.However, returned device analysis revealed the balloon was torn circumferentially.

• 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: 7998464
• Report Number: 2134265-2018-07479
• Device Sequence Number: 19160439
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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: 10/17/2020
• Device Model Number: H7493892812250
• Device Catalogue Number: 38928-1225
• Device Lot Number: 21271723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1