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

Model Number	H7493892809200
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The shafts, balloon, tip and welds were microscopically examined.There was blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic examination revealed a 12mm balloon longitudinal tear along the entire length of the balloon.Inspection of the remainder of the device revealed no other damage or irregularities.No other damage or 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
Reportable based on device analysis completed on 29-jun-2017.It was reported that crossing difficulties were encountered.The patient was diagnosed with single vessel disease (svd).Vascular access was obtained via the femoral artery.The 90% stenosed, 2.5x17mm, concentric, de novo target lesion was located in the mildly tortuous and mildly calcified left circumflex (lcx) artery.After a non-bsc guide wire crossed the lesion, a 2.00mm x 9mm maverick²¿ balloon catheter was advanced for pre-dilatation.However, the device was not able to cross the lesion and after so many efforts, the device was removed.Pre-dilatation was then performed with a 1.50x8mm apex push balloon catheter, followed by the implantation of a 2.50x20mm promus element stent and the procedure was completed.No patient complications were reported and the patient's status was stable and responding well to medicines.However, returned device analysis revealed a longitudinal balloon tear.

• 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: 6709751
• Report Number: 2134265-2017-07070
• Device Sequence Number: 11128996
• Product Code: LOX
• UDI-Device Identifier: 08714729369875
• UDI-Public: (01)08714729369875(17)20190331(10)19064128
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 06/29/2017

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: 03/31/2019
• Device Model Number: H7493892809200
• Device Catalogue Number: 38928-0920
• Device Lot Number: 19064128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: RUNTHROUGH
• Patient Age: 44 YR
• Patient Weight: 65