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

Model Number	H7493808008300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 93% stenosed, 8.00mm in length target lesion was located in the moderately tortuous, calcified and 3.00mm in diameter left anterior descending artery.A 3.0mm x 8mm quantum¿ maverick¿ balloon catheter was advanced for pre-dilatation.However, during the first inflation, the balloon ruptured.The device was completely removed and the procedure was completed with another 3.0mm x 8mm quantum¿ maverick¿ balloon catheter.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 mr balloon catheter.The balloon was loosely folded with blood in the wire and inflation lumen.Microscopic inspection revealed a burst in the balloon material, 6mm in length and numerous kinks in the hypotube, and a kink in the inner shaft (inside the burst area) that was 4mm from the tip.Inspection of the remainder of the device revealed numerous kinks in the hypotube.There is no indication the device was inflated over the 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 balloon rupture occurred.The 93% stenosed, 8.00mm in length target lesion was located in the moderately tortuous, calcified and 3.00mm in diameter left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced for pre-dilatation.However, during the first inflation, the balloon ruptured.The device was completely removed and the procedure was completed with another 3.0mm x 8mm quantum maverick balloon catheter.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: 7732005
• Report Number: 2134265-2018-06838
• Device Sequence Number: 2541564
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: 08714729392569
• 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): 07/11/2018

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: 09/17/2020
• Device Model Number: H7493808008300
• Device Catalogue Number: 38080-0830
• Device Lot Number: 21150979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 68