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

Model Number	H7493808012500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded.The shaft, hypotube, and bonds were microscopically and visually examined.The hypotube was completely separated 22.5cm from the hub.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.There is tip damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There were numerous hypotube and shaft kinks.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in a coronary artery.A 5.0mm x 12mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However, during the procedure, the device delivery shaft was fractured/broken.No patient complications were reported and the patient's status was stable.

• 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: 6785648
• Report Number: 2134265-2017-07790
• Device Sequence Number: 11205335
• Product Code: LOX
• UDI-Device Identifier: 08714729392736
• UDI-Public: (01)08714729392736(17)20200131(10)0020223303
• 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
• Report Date (Section B): 07/19/2017

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: 01/31/2020
• Device Model Number: H7493808012500
• Device Catalogue Number: 38080-1250
• Device Lot Number: 0020223303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1