MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number 24628

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that the blade got separated.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified forearm vein.A 6.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got separated.There were no remnants left inside the body and the procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination was performed on the returned device.It was noted that approximately 17mm of the proximal end of one of the blades and blade pad was lifted distally from the balloon material.The remaining 3mm of the blade and blade pad remained bonded to the balloon material.The entire blade was present and accounted for.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.No issues were identified with the balloon material which could potentially have contributed to this complaint.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found no damage or kinks to the shaft of the device.

Event Description

It was reported that the blade got separated.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified forearm vein.A 6.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got separated.There were no remnants left inside the body and the procedure was completed with a different device.There were no patient complications reported.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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: 13830530
• MDR Text Key: 287534298
• Report Number: 2134265-2022-02878
• Device Sequence Number: 1
• Product Code: LIT
• 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,Followup
• Report Date: 04/27/2022

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: 09/07/2023
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0027972931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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