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

Model Number	H7493892812350
Medical Device Problem Codes	Bent (1059); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 85.1cm from the hub.The fracture faces were oval as if kinked prior to separation.There is shaft damage at the exit notch that is consistent with damage seen with the use of a guidewire.The tip is damaged.There are numerous hypotube and shaft kinks.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.The investigation conclusion is operational context as the product meets the design and 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 (b)(6) 2017.It was reported that crossing difficulties were encountered and shaft damage occurred.The 82% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery.Following pre-dilation with a 3.0x12mm non-bsc balloon catheter, a 3.50mmx12mm maverick balloon catheter was advanced for dilation.However, the device failed to cross the lesion and the mid shaft was damaged.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube break.

• 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: 7159280
• Report Number: 2134265-2017-12776
• Device Sequence Number: 738594
• Product Code: LOX
• UDI-Device Identifier: 08714729370024
• UDI-Public: 08714729370024
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 12/12/2017

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: 07/24/2020
• Device Model Number: H7493892812350
• Device Catalogue Number: 38928-1235
• Device Lot Number: 20927687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR