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

Model Number	H7493808015400
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed, 15x4.00mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.During unpacking of a 4.0mm x 15mm quantum¿ maverick¿ balloon catheter, it was noted that the device delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded.The shaft is intact; there is no shaft separation.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.There are numerous hypotube and shaft kinks.Inspection of the remainder of the device revealed no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.Bsc id: (b)(4), tw: (b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed, 15x4.00mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.During unpacking of a 4.0mm x 15mm quantum¿ maverick¿ balloon catheter, it was noted that the device delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and 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: 7204334
• Report Number: 2134265-2018-00039
• Device Sequence Number: 1174681
• Product Code: LOX
• UDI-Device Identifier: 08714729392828
• UDI-Public: 08714729392828
• 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): 12/28/2017

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: 05/17/2020
• Device Model Number: H7493808015400
• Device Catalogue Number: 38080-1540
• Device Lot Number: 0020663866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1