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

Model Number	H7493808008400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 18mm x 3.5mm target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 4.0mm x 8mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion.However, it was noted that the shaft had fractured.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 lot number corrected from 19259204 to 19133634.Device expiration date corrected from 05/31/2019 to 04/30/2019.Device manufactured date corrected from 05/16/2016 to 04/12/2016.Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter in two pieces.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.The shaft, hypotube, and bonds were microscopically and visually examined.There were numerous hypotube and shaft kinks throughout the device.There was also, a complete hypotube separation 55.5cm from the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.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 shaft break occurred.The 90% stenosed, 18mm x 3.5mm target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 4.0mm x 8mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion.However, it was noted that the shaft had fractured.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: 6178460
• Report Number: 2134265-2016-11686
• Device Sequence Number: 993536
• Product Code: LOX
• UDI-Device Identifier: 08714729392606
• UDI-Public: (01)08714729392606(17)20190531(10)19259204
• 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): 11/30/2016

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: 04/30/2019
• Device Model Number: H7493808008400
• Device Catalogue Number: 38080-0840
• Device Lot Number: 19133634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1