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

Model Number	7585
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 81% stenosed, 30mm x 3.0mm target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, during procedure, the balloon delivery shaft was fractured at 20cm from the distal end of the balloon.The device was simply pulled out and completely removed from the patient's body.The procedure was completed with another of the same device.There were no complications reported and the patient's status was stable.
Additional Manufacturer Narrative
D4 model/catalog number corrected from 7005 to 7585.D4 lot number corrected from 0024551500 to 0024618135.D4 expiration date corrected from 10/06/2022 to 10/17/2022.D4 unique identifier corrected from (b)(4).H4 device manufacture date corrected from 10/07/2019 to 10/18/2019 device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a shaft kink 81mm proximal from the tip.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The 81% stenosed, 30mm x 3.0mm target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, during procedure, the balloon delivery shaft was fractured at 20cm from the distal end of the balloon.The device was simply pulled out and completely removed from the patient's body.The procedure was completed with another of the same device.There were no complications reported and the patient's status was stable.A 3.0mm x 8mm quantum maverick balloon catheter initially reported and correct device should have been a 2.50mm x 15mm maverick balloon catheter.
Event or Problem Description
It was reported that shaft break occurred.The 81% stenosed, 30mm x 3.0mm target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, during procedure, the balloon delivery shaft was fractured at 20cm from the distal end of the balloon.The device was simply pulled out and completely rmoved from the patient's body.The procedure was completed with another of the same device.There were no complications reported and the patient's status was stable.A 3.0mm x 8mm quantum maverick balloon catheter initially reported and correct device should have been a 2.50mm x 15mm maverick balloon catheter.
Additional Manufacturer Narrative
D4 model/catalog number corrected from 7005 to 7585.D4 lot number corrected from 0024551500 to 0024618135.D4 expiration date corrected from 10/06/2022 to 10/17/2022.D4 unique identifier corrected from (b)(4) to (b)(4).H4 device manufacture date corrected from 10/07/2019 to 10/18/2019.

• 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: 10559987
• Report Number: 2134265-2020-12117
• Device Sequence Number: 2627780
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: 08714729392569
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2020

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: 10/17/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0024618135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/09/2020; 12/08/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/25/2020; 12/15/2020
• 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: 61