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

Model Number	H7493808015400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary artery.A 4.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation; however, the balloon ruptured.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.: the returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded with blood in the wire and inflation lumen.Microscopic inspection revealed a burst in the balloon material, 9mm in length.Inspection of the remainder of the device revealed numerous kinks in the hypotube.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 4.0mm x 15mm quantum¿ maverick¿ balloon catheter was advanced for dilatation; however, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 6744110
• Report Number: 2134265-2017-07560
• Device Sequence Number: 725013
• Product Code: LOX
• UDI-Device Identifier: 08714729392828
• UDI-Public: (01)08714729392828(17)20191231(10)20049473
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 07/12/2017

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: 12/31/2019
• Device Model Number: H7493808015400
• Device Catalogue Number: 38080-1540
• Device Lot Number: 20049473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1