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

Model Number	H7493808008270
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that shaft break and balloon rupture occurred.The 95% stenosed, 7mm in length target lesion was located in the moderately tortuous, moderately calcified and 2.75mm in diameter left anterior descending (lad) artery.A 2.75mmx8mm quantum¿ maverick¿ balloon catheter was advanced for dilation.However, upon the first inflation at 10 atmospheres, the balloon ruptured.It was also noted that the shaft fractured at about 70cm from the handle.The device was completely removed 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.The reported batch number for this complaint was 20796311, but the batch number on the returned device was 20866104.The balloon was loosely folded with fluid in the balloon and inflation lumen.The hub, hypotube, inner/outer shaft, balloon, markerbands and tip were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube, and a pinhole in the balloon material located 2mm proximal to the distal markerband.The hypotube of the device was intact.Functional testing of the device was done by attaching an inflation device, filled with water, to the hub of the returned device at applying positive pressure.When pressure was applied, water was found to be streaming out from the balloon material.Inspection of the remainder of the device presented no other damage or irregularities.There is no indication the device was inflated over rated burst pressure.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).
Event or Problem Description
It was reported that shaft break and balloon rupture occurred.The 95% stenosed, 7mm in length target lesion was located in the moderately tortuous, moderately calcified and 2.75mm in diameter left anterior descending (lad) artery.A 2.75mmx8mm quantum¿ maverick¿ balloon catheter was advanced for dilation.However, upon the first inflation at 10 atmospheres, the balloon ruptured.It was also noted that the shaft fractured at about 70cm from the handle.The device was completely removed and the procedure was completed with another of the same device.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: 7134802
• Report Number: 2134265-2017-12612
• Device Sequence Number: 1068969
• Product Code: LOX
• UDI-Device Identifier: 08714729392552
• UDI-Public: 08714729392552
• 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): 12/06/2017

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: 06/20/2020
• Device Model Number: H7493808008270
• Device Catalogue Number: 38080-0827
• Device Lot Number: 0020796311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 58