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

Model Number	7005
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned device consisted of a quantum maverick balloon catheter hypotube.The balloon, distal shaft and hub/strain relief was not returned for analysis.The hypotube was microscopically and visually inspected.Inspection revealed 73cm of the hypotube returned with both fractured ends ovaled, as if kinked prior to separation and there were numerous kinks in the hypotube.The fracture faces of the hypotube were ovaled, as if kinked prior to separation.Inspection of the rest of the device found no other damage.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty.
Event or Problem Description
Reportable based on device analysis completed on 14-may-2019.It was reported that crossing difficulty was encountered.The target lesion was located in the left circumflex artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilatation but failed to cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a separated hypotube.
Additional Manufacturer Narrative
Describe event or problem updated.Device evaluated by mfr.: returned device consisted of a quantum maverick balloon catheter hypotube.The balloon, distal shaft and hub/strain relief was not returned for analysis.The hypotube was microscopically and visually inspected.Inspection revealed 73cm of the hypotube returned with both fractured ends ovaled, as if kinked prior to separation and there were numerous kinks in the hypotube.The fracture faces of the hypotube were ovaled, as if kinked prior to separation.Inspection of the rest of the device found no other damage.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that crossing difficulty was encountered.The target lesion was located in the left circumflex artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilatation but failed to cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a separated hypotube.It was further reported that when the device was attempted to cross the lesion, the shaft broke.

• 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: 8679236
• Report Number: 2134265-2019-06560
• Device Sequence Number: 13971463
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: 08714729392569
• 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): 07/01/2019

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: 08/07/2021
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0022487753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 71