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

Model Number	7010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 4.0mm x 12mm quantum maverick balloon catheter was selected for use.However, during unpacking, it was noted that the balloon catheter was fractured.The procedure was completed with a different device.There were no patient complications reported and the patient condition was stable.
Additional Manufacturer Narrative
(d4) lot number corrected from 0024511430 to 0023230316.Expiration date corrected from 09/29/2022 to 01/22/2022.(h4) device manufacture date corrected from 09/30/2019 to 01/23/2019.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 complete separation at 2mm distal of the strain relief.The hypotube fracture surface of the hypotube separation was ovaled indicating the hypotube was kinked prior to separation.The product mandrel and balloon protector were in place.The balloon was tightly 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.A 4.0mm x 12mm quantum maverick balloon catheter was selected for use.However, during unpacking, it was noted that the balloon catheter was fractured.The procedure was completed with a different device.There were no patient complications reported and the patient condition was stable.
Event or Problem Description
It was reported that shaft break occurred.A 4.0mm x 12mm quantum maverick balloon catheter was selected for use.However, during unpacking, it was noted that the balloon catheter was fractured.The procedure was completed with a different device.There were no patient complications reported and the patient condition was stable.
Additional Manufacturer Narrative
(d4): lot number corrected from 0024511430 to 0023230316.Expiration date corrected from 09/29/2022 to 01/22/2022.(h4) device manufacture date corrected from 09/30/2019 to 01/23/2019.

• Brand Name: QUANTUM 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: 10501214
• Report Number: 2134265-2020-11494
• Device Sequence Number: 2680081
• Product Code: LOX
• UDI-Device Identifier: 08714729392712
• UDI-Public: 08714729392712
• 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): 11/05/2020

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: 01/22/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0023230316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/25/2020; 10/19/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/14/2020; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 60