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

Model Number 7585

Device Problem Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in a coronary artery.A 2.50mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, during initial inflation at 15 atmospheres for 20 seconds, it it was noticed that the balloon was leaking.The device was removed and a pinhole was noted on the balloon.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

H3 device eval by manufacturer?: yes initially reported and corrected selection to no.Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.The balloon was loosely folded.There were pinholes at the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in the coronary artery.A 2.50mm x 15mm maverick 2 balloon catheter was advanced.After the initial inflation at 15 atmospheres for 20 seconds, it was found leaking gas.The physician withdrew the balloon and found the leaking hole of the balloon.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in the coronary artery.A 2.50mm x 15mm maverick 2 balloon catheter was advanced.After the initial inflation at 15 atmospheres for 20 seconds, it was found leaking gas.The physician withdrew the balloon and found the leaking hole of the balloon.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

H3 device eval by manufacturer?: yes initially reported and corrected selection to no.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11229941
• MDR Text Key: 228682351
• Report Number: 2134265-2021-00543
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• UDI-Public: 08714729370086
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0025143827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/07/2021; 03/02/2021
• Supplement Dates FDA Received: 01/26/2021; 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 68