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

Model Number	H7493808015320
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 28x3mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.A 3.25mm 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: returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.12mm of the shaft is buckled starting 138.3cm from the hub.The tip is damaged.Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device, and inflating the device to rated burst pressure (rbp).The quantum maverick device inflated and held pressure for 5 minutes without leaking.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There were numerous hypotube and shaft kinks.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 28x3mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.A 3.25mm 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: 6991018
• Report Number: 2134265-2017-10849
• Device Sequence Number: 489009
• Product Code: LOX
• UDI-Device Identifier: 08714729392798
• UDI-Public: 08714729392798
• 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): 10/16/2017

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: 10/31/2019
• Device Model Number: H7493808015320
• Device Catalogue Number: 38080-1532
• Device Lot Number: 0019845402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1