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

Model Number 3850

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the device was fractured.A 6mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the device became fractured when advancing into the patient.Furthermore, there were kinks noted on the device.The balloon catheter was removed directly and the procedure was completed with another of the same device.No device fragments were left inside the patient's body.There were no complications reported and the patient was stable post procedure.

Event Description

It was reported that the device was fractured.A 6mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the device became fractured when advancing into the patient.Furthermore, there were kinks noted on the device.The balloon catheter was removed directly and the procedure was completed with another of the same device.No device fragments were left inside the patient's body.There were no complications reported and the patient was stable post procedure.It was further reported that the 80% stenosed target lesion was mildly tortuous and moderately calcified.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) university.Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon wings were found to be wrapped.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the shaft of the device.A hypotube break was identified at 76cm proximal from the tip of the device.The proximal section of the device including the manifold was not returned for analysis.A hypotube kink was also noted at 46 cm proximal from the tip.A kink was present in the midshaft at 2mm proximal to the guidewire port.

• 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
• MDR Report Key: 11631102
• MDR Text Key: 244385515
• Report Number: 2134265-2021-03916
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

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: 10/16/2022
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0026201410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 78