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

Model Number	H7493892820300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A 3.00mm x 20mm maverick²¿ balloon catheter was advanced for pre-dilatation.However, during inflation at 6 atmospheres for 3 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The balloon was loosely folded.There are numerous hypotube and shaft kinks.Microscopic examination revealed that the balloon has a 15mm longitudinal tear starting at the proximal balloon weld.There is no indication the device was inflated over rated burst pressure.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
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A 3.00mm x 20mm maverick²¿ balloon catheter was advanced for pre-dilatation.However, during inflation at 6 atmospheres for 3 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and 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: 7172609
• Report Number: 2134265-2017-13026
• Device Sequence Number: 16437683
• Product Code: LOX
• UDI-Device Identifier: 08714729370208
• UDI-Public: 08714729370208
• 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,Followup
• Report Date (Section B): 12/15/2017

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: 06/20/2020
• Device Model Number: H7493892820300
• Device Catalogue Number: 38928-2030
• Device Lot Number: 0020797311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR