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

Model Number	H7493808020250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
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 medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.A 2.5mmx20mm quantum¿ maverick¿ balloon catheter was advanced for dilation and the device was initially inflated at 12 atmospheres for 10 seconds.Second inflation was performed at 14 atmospheres for 10 seconds; however, during the third inflation at 18 atmospheres for 10 seconds, the balloon deflated slowly by itself before deflation.The device was completely removed from the patient.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter with a product mandrel and a balloon protector.The balloon was tightly folded.Microscopic inspection found no damage or irregularities.Functional testing was performed and the device was brought to rated burst pressure (rbp).The device held pressure for 5 minutes and did not leak or lose pressure.There is no indication the device was inflated over rated burst pressure.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.A 2.5mmx20mm quantum¿ maverick¿ balloon catheter was advanced for dilation and the device was initially inflated at 12 atmospheres for 10 seconds.Second inflation was performed at 14 atmospheres for 10 seconds; however, during the third inflation at 18 atmospheres for 10 seconds, the balloon deflated slowly by itself before deflation.The device was completely removed from the patient.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

• Brand Name: QUANTUM¿ MAVERICK¿
• 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: 6187263
• Report Number: 2134265-2016-11847
• Device Sequence Number: 1418989
• Product Code: LOX
• UDI-Device Identifier: 08714729392873
• UDI-Public: (01)08714729392873(17)20190930(10)19704102
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2016

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: 09/30/2019
• Device Model Number: H7493808020250
• Device Catalogue Number: 38080-2025
• Device Lot Number: 19704102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR