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

Model Number	H7493808008320
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded.There was contrast in the inflation lumen.There was blood in between balloon folds.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 52.5 cm from the hub.The fracture faces were oval as if kinked prior to separation.There were numerous hypotube kinks.There was tip damage.Inspection of the remainder of the device presented no other damage or irregularities.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
Reportable based on device analysis completed on 01-nov-2016.It was reported that crossing difficulties were encountered.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified coronary artery.A 3.25mm x 8mm quantum¿ maverick¿ was advanced but failed to cross the lesion.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed the hypotube break.

• 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: 6119589
• Report Number: 2134265-2016-10447
• Device Sequence Number: 11026222
• Product Code: LOX
• UDI-Device Identifier: 08714729392576
• UDI-Public: (01)08714729392576(17)20181231(10)18757606
• 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
• Report Date (Section B): 11/01/2016

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: 12/31/2018
• Device Model Number: H7493808008320
• Device Catalogue Number: 38080-0832
• Device Lot Number: 18757606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 87