MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE QUANTUM¿ MAVERICK¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493808008370
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Bsc id: (b)(4).Tw: (b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed, 30mm in length target lesion was located in the severely tortuous, mildly calcified and 3.75mm in diameter proximal to mid left anterior descending artery.A 3.75mm x 8mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However, the shaft was fractured.The device was removed with the guide catheter and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed, 30mm in length target lesion was located in the severely tortuous, mildly calcified and 3.75mm in diameter proximal to mid left anterior descending artery.A 3.75mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, the shaft was fractured.The device was removed with the guide catheter and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 77.8cm from the hub.The fracture faces were oval as if kinked prior to separation.There are numerous hypotube and shaft kinks.The tip is damaged.The shaft is damaged at the exit notch which is consistent with damage seen with the use of a guidewire.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: QUANTUM¿ MAVERICK¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7663939
• Report Number: 2134265-2018-05932
• Device Sequence Number: 19327694
• Product Code: LOX
• UDI-Device Identifier: 08714729392590
• UDI-Public: 08714729392590
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Report Date (Section B): 06/12/2018

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: 09/07/2020
• Device Model Number: H7493808008370
• Device Catalogue Number: 38080-0837
• Device Lot Number: 0021112317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 76