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

Model Number	H7493808012450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.A 4.5mmx12mm quantum¿ maverick¿ balloon catheter was advanced for dilation.However, the shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.A 4.5mmx12mm quantum¿ maverick¿ balloon catheter was advanced for dilation.However, the shaft was fractured.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., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded.The shaft is intact; there is no shaft separation.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.There are numerous hypotube kinks.There is shaft damage at the exit notch that is consistent with damage seen with the use of a guidewire.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage.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).

• 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: 7290095
• Report Number: 2134265-2018-01145
• Device Sequence Number: 1741936
• Product Code: LOX
• UDI-Device Identifier: 08714729392729
• UDI-Public: 08714729392729
• 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): 01/30/2018

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: 04/30/2020
• Device Model Number: H7493808012450
• Device Catalogue Number: 38080-1245
• Device Lot Number: 0020485215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1