MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7005
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed, 20-22mm in length, 2.5-2.75mm in vessel diameter, target lesion was located in the moderately tortuous and mildly calcified left circumflex artery.A 2.5mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, during the first inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.Examination revealed that the hypotube had numerous kinks and the hub was broken off and not returned.Functional testing was not able to be completed as the hub was broken off.Microscopic inspection did not reveal any issues or damage to the balloon.The reported balloon burst was not confirmed.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed, 20-22mm in length, 2.5-2.75mm in vessel diameter, target lesion was located in the moderately tortuous and mildly calcified left circumflex artery.A 2.5mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, during the first inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries 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 CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9560571
• Report Number: 2134265-2019-16548
• Device Sequence Number: 16738151
• Product Code: LOX
• UDI-Device Identifier: 08714729392545
• UDI-Public: 08714729392545
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/05/2020

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: 04/30/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0023723237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 65