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

Model Number	H7493892809200
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The balloon and tip were microscopically and visually examined.There was contrast in the inflation lumen.The balloon was loosely folded.Microscopic examination of the balloon revealed that there was a longitudinal tear from the proximal to distal ends of the balloon.Microscopic examination presented no irregularities in the balloon material or the markerband that could have contributed to the damage.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
Reportable based on device analysis completed on 17-may-2017.It was reported that balloon inflation failure occurred.The 75% stenosed, 22mm in length, concentric, de novo target lesion was located in the mildly tortuous, severely calcified, and 3.00mm in diameter right coronary artery (rca).The lesion contained >45 and <90 degrees bend.After a non-bsc guide catheter was engaged and a non-bsc guide wire crossed the lesion, a 2.00mm x 9mm maverick²¿ balloon catheter was advanced for pre-dilation.The balloon was inflated twice; however, when the balloon was inflated at 8 atmospheres, it was noted that the balloon could not be inflated.The device was removed from the patient fully deflated and intact.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.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: 6603253
• Report Number: 2134265-2017-05439
• Device Sequence Number: 18995071
• Product Code: LOX
• UDI-Device Identifier: 08714729369875
• UDI-Public: (01)08714729369875(17)20191031(10)19881069
• 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): 05/17/2017

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: H7493892809200
• Device Catalogue Number: 38928-0920
• Device Lot Number: 19881069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 58