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

Model Number 3852

Device Problem Difficult to Open or Remove Packaging Material (2922)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter email: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual and microscopic examination identified that a break had occurred in the inner and outer extrusions.The break in the inner was located at 25cm distal from the port.The break in the outer was measured at 39cm distal to the port site.The distal sections of the break including the balloon and tip was not returned for analysis.The distal extrusion was severely stretched.A visual and tactile examination of the hypotube identified no issues.Both the proximal and distal markerbands had detached from the inner and were positioned inside the clear outer extrusion.No damage was observed on each markerband.

Event Description

Reportable based on device analysis completed on (b)(6)2023.It was reported that the device was stuck inside sleeve.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During preparation, the balloon got stuck inside the sleeve upon removing the stylet.No complications were reported.However, device analysis revealed a break had occurred in the inner and outer extrusions.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16637115
• MDR Text Key: 312234272
• Report Number: 2124215-2023-14146
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2023

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: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0029552018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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