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

Model Number	H7493808012320
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter with no other devices.The balloon was tightly folded and there was blood in the wire lumen.The hypotube, inner shaft and outer shaft were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube, and a complete separation in the hypotube located 68cm from the strain relief.The fracture faces were oval, as if kinked prior to separation.Inspection of the remainder of the device, apart from the observed damage, revealed 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 29jun2017.It was reported that shaft kink occurred.A 3.25mm x 12mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However the shaft kinked.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However returned device analysis revealed a hypotube broken at a portion that could enter the patient's body.

• 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: 6723318
• Report Number: 2134265-2017-07038
• Device Sequence Number: 10809943
• Product Code: LOX
• UDI-Device Identifier: 08714729392682
• UDI-Public: (01)08714729392682(17)20190831(10)19662523
• 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): 06/29/2017

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: 08/31/2019
• Device Model Number: H7493808012320
• Device Catalogue Number: 38080-1232
• Device Lot Number: 19662523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1