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

Model Number	H7493892825200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery (rca).A 2.00mm x 25mm maverick²¿ balloon catheter was advanced through a guide catheter for dilatation.However, it was noted that the catheter broke in half.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a maverick 2 balloon catheter with no other devices.The balloon was loosely folded with blood in the balloon and inflation lumen.The hypotube, distal shaft, balloon and tip of the device were microscopically and tactile inspected.Inspection revealed that there was numerous kinks in the hypotube and was separated 71.5 cm from the strain relief.The fracture faces were oval as if kinked prior to separation.There was no evidence of any material or manufacturing deficiencies contributing to the damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery (rca).A 2.00mm x 25mm maverick balloon catheter was advanced through a guide catheter for dilatation.However, it was noted that the catheter broke in half.The procedure was completed with a different device.No patient complications were reported.

• 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: 6677882
• Report Number: 2134265-2017-06479
• Device Sequence Number: 13464091
• Product Code: LOX
• UDI-Device Identifier: 08714729370253
• UDI-Public: (01)08714729370253(17)20200229(10)20313582
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2017

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: 02/29/2020
• Device Model Number: H7493892825200
• Device Catalogue Number: 38928-2520
• Device Lot Number: 20313582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR