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

Model Number	H7493892809200
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.During preparation of a 2.00mm x 9mm maverick²¿ balloon catheter, upon wiring the balloon, it was noted that the balloon snapped off.The device was not used inside the patient and the procedure was completed with a emerge balloon catheter.No patient complications were reported and the patient's status was good.
Additional Manufacturer Narrative
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 shaft was completely separated 91.7cm from the hub.The fracture faces were oval as if kinked prior to separation.There are numerous hypotube and shaft kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.During preparation of a 2.00mm x 9mm maverick²¿ balloon catheter, upon wiring the balloon, it was noted that the balloon snapped off.The device was not used inside the patient and the procedure was completed with a emerge balloon catheter.No patient complications were reported and the patient's status was good.

• 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: 7566965
• Report Number: 2134265-2018-04872
• Device Sequence Number: 16801709
• Product Code: LOX
• UDI-Device Identifier: 08714729369875
• UDI-Public: 08714729369875
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P860019
• 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,Followup
• Report Date (Section B): 05/09/2018

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: 02/02/2021
• Device Model Number: H7493892809200
• Device Catalogue Number: 38928-0920
• Device Lot Number: 21698215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1