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

Model Number	H7493892809200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental med watch will be filed.(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary artery.A 2.00mm x 9mm maverick²¿ balloon catheter was advanced for dilation.However the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.There were no patient complications and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of the maverick 2 balloon catheter.There was blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic examination of the balloon revealed no damage however, the distal tip was damaged.Functional testing was performed by attaching an inflation device filled with water to the device.When positive pressure was applied, two streams of water emitted from the balloon wall.The balloon was microscopically examined and two pinholes in the balloon wall at the proximal end of the distal markerband were revealed.There were two deep scratches to the left and right of the pinholes.Microscopic examination presented no irregularities in the balloon material or markerband that could have contributed to the damage.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 balloon rupture occurred.The target lesion was located in a coronary artery.A 2.00mm x 9mm maverick²¿ balloon catheter was advanced for dilation.However the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.There were no patient complications and the patient's status was fine.

• 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: 6673830
• Report Number: 2134265-2017-06568
• Device Sequence Number: 45503
• Product Code: LOX
• UDI-Device Identifier: 08714729369875
• UDI-Public: (01)08714729369875(17)20200331(10)20472872
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/13/2017

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: 03/31/2020
• Device Model Number: H7493892809200
• Device Catalogue Number: 38928-0920
• Device Lot Number: 20472872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR