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

Model Number	7580
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.When received, there was contrast in the inflation lumen.The balloon was tightly folded.There were numerous kinks throughout the hypotube with a complete hypotube separation 74.5cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Product analysis confirmed the reported shaft kink, as the hypotube had numerous kinks and a complete separation resulting from a kink.However, the reported crossing difficulty could not be confirmed because the clinical circumstances could not be replicated.
Event or Problem Description
Reportable based on device analysis completed on 13nov2019.It was reported that crossing difficulties and shaft kink were encountered.Vascular access was obtained via the femoral artery.The concentric target lesion with a bend of >= 90 degrees was located in the mildly calcified mid right coronary artery.A 2.50mm x 12mm maverick 2 balloon catheter was selected for use.However, during procedure, it failed to cross the lesion and an acute kinked was noted with the balloon shaft.The procedure was completed with another balloon with the support of guidezilla.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.

• Brand Name: 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: 9404474
• Report Number: 2134265-2019-14838
• Device Sequence Number: 13994994
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 12/03/2019

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: 03/26/2021
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0021916181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 72