MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed, 12mm in length target lesion was located in the moderately tortuous, calcified, and 4mm in diameter left anterior descending artery.A 4.0mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, upon inflation at 16 atmospheres, the balloon ruptured.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed, 12mm in length target lesion was located in the moderately tortuous, calcified, and 4mm in diameter left anterior descending artery.A 4.0mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, upon inflation at 16 atmospheres, the balloon ruptured.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded with blood in the inflation lumen and balloon.The tip is damaged.There are numerous hypotube and shaft kinks.The device was hooked up to an inflation device and it leaked out of the shaft near the exit notch.The midshaft was found to have a puncture hole 117.5cm from the hub which is consistent with the damage that is seen by the use of a guidewire.The device would not inflate correctly due to the shaft hole.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7785584
• Report Number: 2134265-2018-60082
• Device Sequence Number: 186347
• Product Code: LOX
• UDI-Device Identifier: 08714729392712
• UDI-Public: 08714729392712
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/06/2018

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: 02/07/2021
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0021718954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65