MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3851

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis: a visual examination identified that the balloon folds were tightly wrapped.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination found that the device was received in two sections as a result of a break in the hypotube.The break was located at 20.9 cm distal to the strain relief.Both section of the hypotube were kinked near the break site.This type of damage is consistent with excessive force that could have been applied to the delivery system.A visual and tactile examination found a rotational twisting of the outer.This twisting stretched from the proximal balloon sleeve and extended proximally for a total length of 1cm.No damage was observed to the inner/wire lumen at the same location.This type of damage is consistent with excessive force that could have been applied to the delivery system.

Event Description

Reportable based on device analysis completed on (b)(6) 2020.It was reported that the device was unable to cross the lesion.Vascular access was obtained via right femoral artery.The 60% stenosed target lesion area, in-stent restenosis with a >45 degrees bend was located in a moderately tortuous and moderately calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, the balloon was delivered with a non-bsc support wire.However, the device did not cross the lesion due to severe calcification.The device was simply removed from the patient's body.Another wolverine was used and crossed the lesion and completed the procedure.There were no complications reported and the patient was stable.However, device investigation revealed a hypotube break located at 20.9 cm distal to the strain relief.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11131512
• MDR Text Key: 225531193
• Report Number: 2134265-2020-18319
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0025679041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON-WOLVERINE; GUIDEWIRE- WHISPER BUDDY WIRE; GUIDEWIRE-ROTAWIRE FLOPPY; GUIDEWIRE-RUNTHROUGH; ROTALINK PLUS 1.25MM; STENT-PROMUS PREMIER
• Patient Age: 74 YR