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

Model Number 7585

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the shaft, hypotube, tip and balloon were microscopically and visually examined.There was a complete separation at 72.5cm distal of the strain relief.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported difficulties inflating the balloon.

Event Description

Reportable based on device analysis completed on 24-mar-2021.It was reported that inflation failure was encountered.The 85% stenosed, 22mm x 4.1mm target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation, the balloon failed to inflate.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 shaft detached.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11652577
• MDR Text Key: 245100186
• Report Number: 2134265-2021-04121
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: 08714729370062
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0024371772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 71