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

Model Number 3852

Device Problems Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 04/23/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address (b)(6).

Event Description

It was reported that device contamination occurred.The 90% stenosed target lesion was located in the left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, while performing percutaneous transluminal coronary angioplasty (ptca), they opened the 15mmx2.50mm wolverine coronary cutting balloon and after opening some starches were observed on the shaft.Then, after trying to advance the catheter balloon through the hub it got damage.There were no patient complications reported.

Manufacturer Narrative

E initial reporter address (b)(6).H6: updated device code.

Event Description

It was reported that some starches was seen on the shaft.The 90% stenosed target lesion was located in the left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, while performing percutaneous transluminal coronary angioplasty (ptca), they opened the 15mmx2.50mm wolverine coronary cutting balloon and after opening some starches was seen on the shaft.Then, after trying to advance the catheter balloon through the hub it got damage.There were no patient complications reported.It was further reported that the hub was kinked and then got broken.

Manufacturer Narrative

E.Initial reporter address 1: (b)(6) h6: updated device code.

Event Description

It was reported that some starches was seen on the shaft.The 90% stenosed target lesion was located in the left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, while performing percutaneous transluminal coronary angioplasty (ptca), they opened the 15mmx2.50mm wolverine coronary cutting balloon and after opening some starches was seen on the shaft.Then, after trying to advance the catheter balloon through the hub it got damage.There were no patient complications reported.It was further reported that the hub was kinked and then got broken.In addition, after attempting to advance the wolverine device through the hub of a guide catheter, the balloon shaft got damaged in the form of scratch.

Manufacturer Narrative

E.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was in a deflated state.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.The device was received in two sections as a result of a break in the hypotube.The break was located at 22.5 cm distal to the strain relief.Both sections of the hypotube were kinked at various locations.This type of damage is consistent with excessive force that could have been applied to the delivery system.A detailed microscopic examination of both sections of hypotube identified no foreign material or staining adhering to the hypotube shaft.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.A detailed microscopic examination of extrusion identified no foreign material or staining adhering to the hypotube shaft.No other issues were identified during the product analysis.

Event Description

It was reported that some starches was seen on the shaft.The 90% stenosed target lesion was located in the left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, while performing percutaneous transluminal coronary angioplasty (ptca), they opened the 15mmx2.50mm wolverine coronary cutting balloon and after opening some starches was seen on the shaft.Then, after trying to advance the catheter balloon through the hub it got damage.There were no patient complications reported.It was further reported that the hub was kinked and then got broken.In addition, after attempting to advance the wolverine device through the hub of a guide catheter, the balloon shaft got damaged in the form of scratch.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15183535
• MDR Text Key: 298073757
• Report Number: 2124215-2022-29453
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2022

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 Expiration Date: 10/28/2023
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0028281864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 08/23/2022; 08/26/2022; 11/25/2022
• Supplement Dates FDA Received: 08/25/2022; 09/08/2022; 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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
• Patient Sex: Male
• Patient Race: Asian