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

Model Number	H7493808012370
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter with an unidentified.014 guidewire in the guidewire lumen.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.There are numerous hypotube and shaft kinks.The inner shaft is buckled in numerous locations.The inner is separated/torn 3.5mm from the exit notch.The fractured/separated ends of the inner shaft were stretched and jagged which indicates the shaft separation was due to tensile forces.The damage is consistent with the damage that is seen caused by use of a guidewire.The guidewire could not be removed from the catheter due to the damage caused by the guidewire. the investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 26-may-2018.It was reported that crossing difficulties were encountered.The 90% stenosed and 12mm x 3.75mm target lesion was located in the severely tortuous and moderately calcified left circumflex artery.A 3.75mm x 12mm quantum¿ maverick¿ balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another 3.75mm x 12mm quantum¿ maverick¿ balloon catheter.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed catheter entrapment and shaft separation.

• 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: 7620514
• Report Number: 2134265-2018-05353
• Device Sequence Number: 1695230
• Product Code: LOX
• UDI-Device Identifier: 08714729392705
• UDI-Public: 08714729392705
• 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): 05/26/2018

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: 06/04/2020
• Device Model Number: H7493808012370
• Device Catalogue Number: 38080-1237
• Device Lot Number: 0020730234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1