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

Model Number 3851

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that contamination occurred.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that a blood-like stain has adhered onto the delivered device.The device was not used.No patient complications were reported.

Manufacturer Narrative

(b)(6).

Event Description

It was reported that contamination occurred.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that a blood-like stain has adhered on the delivered device.The device was not used.No patient complications were reported.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Received for analysis was the fully sealed wolverine device (batch 28552131) in its box.The box carton was sealed in a clear plastic covering.An examination of the box confirmed what was received in the photo images.A red stain was noted on the box label.The stain did not hide any of the product information on the box label.Further examinations of the box identified a small section of the image of the balloon on the box was missing.The outer seal on the box was fully intact and the clear plastic did not appear to have been opened.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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13792483
• MDR Text Key: 287338388
• Report Number: 2134265-2022-03004
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

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: 12/14/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028552131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• 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