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

Model Number	H7493808008270
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: 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 balloon rupture occurred.The 80% stenosed, 6x2.75mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 8mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.The balloon was inflated at 1520 kilopascals (kpa) for 30 seconds during the initial and second inflation.However, during the third inflation at 1621 kpa, the balloon ruptured.The device was completely removed from the patient's body 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.There was blood in the inflation lumen and the balloon.The balloon was loosely folded.Microscopic examination of the balloon revealed no damage.Functional testing was performed by attaching an inflation device filled with water to the device.When positive pressure was applied, a stream of water emitted from the balloon wall.The balloon was microscopically examined and a pinhole in the balloon wall at the proximal markerband was revealed.Microscopic examination presented no irregularities in the balloon material or the markerband that could have contributed to the damage.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 balloon rupture occurred.The 80% stenosed, 6x2.75mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 8mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.The balloon was inflated at 1520 kilopascals (kpa) for 30 seconds during the initial and second inflation.However, during the third inflation at 1621 kpa, the balloon ruptured.The device was completely removed from the patient's body 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: 6523131
• Report Number: 2134265-2017-04305
• Device Sequence Number: 13455632
• Product Code: LOX
• UDI-Device Identifier: 08714729392552
• UDI-Public: (01)08714729392552(17)20190831(10)0019557581
• 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): 04/15/2017

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: 08/31/2019
• Device Model Number: H7493808008270
• Device Catalogue Number: 38080-0827
• Device Lot Number: 0019557581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 05/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 72