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

Model Number	7005
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of a quantum maverick balloon catheter.No hub was present to confirm batch number.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a complete separation 141.5cm proximal from the tip.There were hypotube kinks at 119cm and 63.8 proximal from the tip.Contrast was in the inflation lumen and blood was in the guidewire lumen.The balloon was tightly folded.Microscopic inspection of the device revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 14-may-2019.It was reported that crossing difficulties were encountered.The target lesion was located in the right coronary artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilation; however, the device failed to cross the lesion.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 a hypotube separation.
Additional Manufacturer Narrative
Returned product consisted of a quantum maverick balloon catheter.No hub was present to confirm batch number.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a complete separation 141.5cm proximal from the tip.There were hypotube kinks at 119cm and 63.8 proximal from the tip.Contrast was in the inflation lumen and blood was in the guidewire lumen.The balloon was tightly folded.Microscopic inspection of the device revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 14-may-2019.It was reported that crossing difficulties were encountered.The target lesion was located in the right coronary artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilation; however, the device failed to cross the lesion.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 a hypotube separation.It was further reported that the fracture occurred during the procedure and outside the patient's body.

• 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: 8679213
• Report Number: 2134265-2019-06557
• Device Sequence Number: 2522891
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: 08714729392583
• 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,foreig
• 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: 08/08/2021
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0022490728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• 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: 59 YR
• Patient Weight: 75