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

Model Number	H7493892809220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: under 18 years.(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 2.25mm x 9mm maverick balloon catheter was advanced for dilation.However, when the physician attempted to push the balloon in the guide catheter, the device was cut about 40cm from the hub.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter in two pieces.The shaft and hypotube were microscopically and visually examined.There was contrast and blood in the inflation lumen.The balloon was tightly folded.There were numerous hypotube kinks throughout the shaft.There was a complete hypotube separation 78.5cm from the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other damage or issues were identified during the product analysis.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.Bsc id: (b)(4).Tw #: (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 2.25mm x 9mm maverick²¿ balloon catheter was advanced for dilation.However, when the physician attempted to push the balloon in the guide catheter, the device was cut about 40cm from the hub.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 6740438
• Report Number: 2134265-2017-07281
• Device Sequence Number: 1247269
• Product Code: LOX
• UDI-Device Identifier: 08714729369882
• UDI-Public: (01)08714729369882(17)20200131(10)20141961
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 07/05/2017

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: 01/31/2020
• Device Model Number: H7493892809220
• Device Catalogue Number: 38928-0922
• Device Lot Number: 20141961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1