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

Model Number	H7493790960150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: device not returned therefore analysis of complaint device could not be performed.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 90% stenosed target lesion was located in a moderately tortuous and severely calcified coronary artery.A 6.0mm x 15mm maverick¿ xl balloon catheter was advanced for dilation.However, during inflation at 8 atmospheres, the balloon ruptured.The device was simply pulled out and was completely removed from the patient's body.The procedure was completed with another maverick¿ xl balloon catheter.No patient complications were reported and the patient's status was stable.

• Brand Name: MAVERICK¿ XL
• 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: 6782143
• Report Number: 2134265-2017-07913
• Device Sequence Number: 16390080
• Product Code: LOX
• UDI-Device Identifier: 08714729390350
• UDI-Public: (01)08714729390350(17)20170910(10)17274015
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 07/24/2017

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: 09/10/2017
• Device Model Number: H7493790960150
• Device Catalogue Number: 37909-6015
• Device Lot Number: 17274015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1