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 Entrapment of Device (1212); Material Integrity Problem (2978)

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

Event Date 04/11/2022

Event Type  malfunction  

Event Description

It was reported that froze on wire occurred.During a plaque modification (mod) procedure, a 6mm x 3.00mm wolverine cutting balloon (cb) was selected for treatment.It was noticed that the balloon was not well folded.An attempt to pass the balloon on the wire was performed, but while taking the balloon back, it became stuck.The device was removed from the patient.Another 6mm x 3.00 mm wolverine cb was opened from its packaging, but it was noticed that the balloon was not well folded, and was not used for treatment.No patient complications were reported in relation to this event.

Manufacturer Narrative

Ai: physician name received.Device evaluated by mfr: the wolverine cb mr, ous 6mmx3.00mm, catheter lot # 28466977-028 was returned for analysis.This wolverine catheter batch was found to have been built into the one of the following wolverine batches 28561906/28561907/28561908 during a system review.As part of the investigation an e-dhr (electronic device history record) review relating to all three identified wolverine batches was performed and no issues were noted with these batches that may have led to the complaint.A visual inspection of the device found no issues with the balloon of this device.Air was found to be entrapped within the proximal balloon folds, but the folds tightened once negative pressure was applied.This balloon profile was found to conform with wolverine specification.The device was successfully loaded onto a 0.0142 guidewire with no issues noted.Product analysis did not confirm the reported event, as no issue was found with the device.

Event Description

It was reported that froze on wire occurred.During a plaque modification (mod) procedure, a 6mm x 3.00mm wolverine cutting balloon (cb) was selected for treatment.It was noticed that the balloon was not well folded.An attempt to pass the balloon on the wire was performed, but while taking the balloon back, it became stuck.The device was removed from the patient.Another 6mm x 3.00 mm wolverine cb was opened from its packaging, but it was noticed that the balloon was not well folded, and was not used for treatment.No patient complications were reported in relation to this event.It was further reported that negative pressure was applied during preparation.

• 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: 14147971
• MDR Text Key: 289599726
• Report Number: 2134265-2022-04490
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

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 Model Number: 3850
• Device Catalogue Number: 3850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1