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 Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/24/2020

Event Type  Injury  

Event Description

It was reported that the shaft was fractured and remained inside patient.The target lesion was located in the severely calcified left anterior descending artery (lad).A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon crossed the lesion normally, but it got stuck in the proximal lad and failed to be withdrawn.Subsequently, the shaft fractured after several attempts to remove and the body of the balloon remained in the lesion.Then, two emerge balloons, two nc emerge balloons, two synergy stents and a guidezilla were used which adhered the fragment in the vascular wall.The procedure was completed with the device fragment remaining in the patient's body.The patient was sent to the icu and in stable condition.No further complications reported.

Event Description

It was reported that the shaft was fractured and remained inside patient.The target lesion was located in the severely calcified left anterior descending artery (lad).A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon crossed the lesion normally, but it got stuck in the proximal lad and failed to be withdrawn.Subsequently, the shaft fractured after several attempts to remove and the body of the balloon remained in the lesion.Then, two emerge balloons, two nc emerge balloons, two synergy stents and a guidezilla were used which adhered the fragment in the vascular wall.The procedure was completed with the device fragment remaining in the patient's body.The patient was sent to the icu and in stable condition.No further complications reported.

Manufacturer Narrative

Cine/media was returned to the manufacturer: the device was not returned for analysis.Cine images were provided by the customer and were analyzed as part of the product analysis by the investigator.The event description was consistent with the cines provided as balloon separation was observed.The efforts to stabilize this challenging situation were also observed through the implantation of stents which resulted in achieving a flow patent through the area, where the dislodged balloon was localized.An incomplete balloon expansion which was most likely induced by the presence of lesion calcium.

• 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: 10365636
• MDR Text Key: 201671463
• Report Number: 2134265-2020-10064
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0025447636
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR