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 Entrapment of Device (1212); Stretched (1601); Difficult to Advance (2920)

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a catheter entrapment occurred.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.When this device was advanced to the guidewire, it was noted that it was not smooth.Upon removal, the catheter froze on wire.When it was slightly pulled, it seems that the shaft got stretched.The balloon was forcefully pulled out and completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that a catheter entrapment occurred.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.When this device was advanced to the guidewire, it was noted that it was not smooth.Upon removal, the catheter froze on wire.When it was slightly pulled, it seems that the shaft got stretched.The balloon was forcefully pulled out and completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

E1 - initial reporter address: (b)(6).Device evaluated by mfr: the device was returned for analysis.Balloon folds were found to be tightly folded.No issues were noted with the blades or pads of this device.All blades were secure in their pads and all pads were fully secured to the balloon material.The shaft polymer extrusion (wire lumen) was visually and microscopically examined and no damages or blockages were observed.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 hypotube of the device and no issues were noted.The guidewire used by the customer was not returned for analysis.Using another 0.014inch size guidewire, the wire was inserted through the tip and wire lumen with no resistance noted.This was repeated three more times with no resistance noted with the movement of the wire through the wire lumen.No 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; two scimed place; maple grove MN 55311
• MDR Report Key: 11378710
• MDR Text Key: 233500268
• Report Number: 2134265-2021-02002
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026323113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1