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

Model Number	7585
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 31.1cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that there was damage to the shaft.
Event or Problem Description
Reportable based on device analysis completed on 10mar2021.It was reported that shaft damage occurred.During preparation of a 3.50mm x 12mm quantum maverick balloon catheter, it was noted that the delivery shaft was damaged.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed hypotube separation.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that shaft damage occurred.During preparation of a 3.50mm x 12mm quantum maverick balloon catheter, it was noted that the delivery shaft was damaged.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis hypotube separation.This event was reported in error.The complaint device was a 2.00mm x 15mm fg maverick 2 mr balloon catheter and not a 3.50mm x 12mm quantum maverick balloon catheter.There was no device returned for this complaint.
Additional Manufacturer Narrative
B5 describe event or problem: corrected.D4 brand name, model number, lot number, catalog number, expiration date, unique identifier (udi): corrected.D9 device avail for evaluation and returned to manufacturer date: corrected.H3 device eval by manufacturer? device eval by mfr attach? device returned to manufacturer?: corrected.H4 device manufacturer date: corrected.H6 evaluation method codes, evaluation result codes: corrected.H10 additional mfr narrative: corrected.

• 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: 11636069
• Report Number: 2134265-2021-04527
• Device Sequence Number: 11636869
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: 08714729392699
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0024824900
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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: 60