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 Material Rupture (1546); Failure to Advance (2524)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

A2 - age at time of event: 18 years or older.

Event Description

It was reported that a balloon rupture occurred.On an unspecified date, an unknown stent was implanted.An in-stent restenosis was noted in the 99% stenosed, moderately tortuous and severely calcified left coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use in percutaneous coronary intervention (pci).During the procedure, the device could not cross the lesion.It was noted that the balloon could not be inflated and was ruptured.The device was removed using normal method.The balloon was flushed outside the patient's body, and a pinhole rupture was noted near front of the blade.The procedure was completed with another of the same device.No complications were reported and patient good post procedure.

Event Description

It was reported that a balloon rupture occurred.On an unspecified date, an unknown stent was implanted.An in-stent restenosis was noted in the 99% stenosed, moderately tortuous and severely calcified left coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use in percutaneous coronary intervention (pci).During the procedure, the device could not cross the lesion.It was noted that the balloon could not be inflated and was ruptured.The device was removed using normal method.The balloon was flushed outside the patient's body, and a pinhole rupture was noted near front of the blade.The procedure was completed with another of the same device.No complications were reported and patient good post procedure.

Manufacturer Narrative

A2 - age at time of event: 18 years or older.Device evaluated by mfr: a visual examination of the balloon identified no damages and blood was noted within the balloon.No hypotube shaft issues were noted and there were no kinks or damages noted on the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified a pinhole 1mm proximal from the proximal markerband.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues were identified during examination of the extrusion shaft and the tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device was not able to be inflated due to the balloon pinhole.No other issues were identified during the product analysis.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17845793
• MDR Text Key: 324618282
• Report Number: 2124215-2023-49572
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0031765295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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