MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493892812250
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter in two pieces.The balloon and tip were microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen and between the balloon folds.The balloon was tightly folded.There was no damage or irregularities to the balloon.There were numerous kinks throughout the shaft and a complete hypotube separation 65cm 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 damage or issues were identified during the product analysis.Device analysis determined the condition of the returned device was not consistent with the reported information.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 30-mar-2017.It was reported that balloon damage occurred.The target lesion was located in the coronary artery.A 2.50mm x 12mm maverick²¿ balloon catheter was advanced but the balloon was damaged while crossing the lesion.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube broken.

• Brand Name: MAVERICK²¿
• 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: 6488840
• Report Number: 2134265-2017-03571
• Device Sequence Number: 1289757
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: (01)08714729369981(17)20191031(10)19909096
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2017

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: 10/31/2019
• Device Model Number: H7493892812250
• Device Catalogue Number: 38928-1225
• Device Lot Number: 19909096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1