MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE PERIPHERAL CUTTING BALLOON; Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Model Number 39345-401510

Device Problem Entrapment of Device (1212)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that the device became stuck with the guidewire.A wolverine pcb mr ous 4.0 x 15mm was selected for use during a percutaneous transluminal renal angioplasty.During the procedure, the wolverine device became stuck on the guidewire and was not able to move.The wolverine and guidewire were removed from the patient together as a unit.The procedure was then completed using another similar device.No patient complications were reported due to this event.

Manufacturer Narrative

Device evaluation by mfr: the returned product consisted of the wolverine pcb device.A visual examination found that the balloon of the device had not been inflated.The inner guidewire lumen was noted to have accordion damage.The investigator was unable to load the device on to a guidewire due to shaft damage.No other issues were identified with the returned device which could potentially have contributed to the complaint incident.This investigation is assigned a conclusion code of unintended use error caused or contributed to event.This code was selected as the most probable complaint cause based on the information available.The product record review confirmed that this is not a new failure type, and the risk is anticipated.There is no evidence of a manufacturing issue or design issue which could have caused the complaint and there is no evidence that the device failed to meet wolverine pcb design matrix prior to shipping.It is possible that the damage to the shaft occurred due the user gripping the shaft tightly and then applying excessive force to remove the product mandrel from the device, causing the inner guidewire lumen to stretch then accordion.A damaged shaft would have prevented the device from being loaded on to the guidewire.

• Brand Name: WOLVERINE PERIPHERAL CUTTING BALLOON
• 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: 17686440
• MDR Text Key: 322707518
• Report Number: 2124215-2023-48144
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39345-401510
• Device Catalogue Number: 39345-401510
• Device Lot Number: 0031957073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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