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	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 7x2.75mm 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.However, during inflation at 15.0 kilopascals, the balloon ruptured.The device was completely removed from the patient 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: the returned product consisted of a quantum maverick balloon catheter in two pieces.The balloon was tightly folded.The hub, hypotube, inner/outer shaft, balloon and tip were microscopically and tactile inspected.Inspection revealed a complete separation in the hypotube located 51cm from the strain relief.Functional testing was conducted by attaching a toughy to the distal portion of the (broken) hypotube, and an inflation device to the opposite end of toughy and applying positive pressure.The balloon was able to be inflated to rated burst pressure (rbp) and holding pressure for 5 minutes, without losing pressure.Inspection of the remainder of the device presented no other damage or irregularities.There is no indication the device was inflated over rbp.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.Bsc id: (b)(4).Tw: (b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 7x2.75mm 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.However, during inflation at 15.0 kilopascals, the balloon ruptured.The device was completely removed from the patient 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: 7112719
• Report Number: 2134265-2017-12570
• Device Sequence Number: 1450264
• 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): 12/05/2017

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: 05/04/2020
• Device Model Number: H7493808008270
• Device Catalogue Number: 38080-0827
• Device Lot Number: 20609468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 80