MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 24658

Device Problems Difficult to Remove (1528); Stretched (1601)

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

Event Date 04/14/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 02jun2022.It was reported that the protective sheath did not come out and the monorail lumen was stretched when the shaft was pulled out.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, it was noted that the protective sheath did not come out and the monorail lumen was stretched when the shaft was pulled out.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed that a shaft break occurred.

Manufacturer Narrative

Initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination identified a complete break in the polymer extrusion 253mm proximal of the distal tip.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination identified that the balloon protector was still on the balloon but had moved in a distal direction.The investigator was unable to apply a vacuum to the device as per preparation instructions indicated in spcb ifu due to a shaft break.For investigation purposes the investigator removed the balloon protector with a little resistance experienced as negative pressure could not be applied to the device.The balloon folds on the proximal end were relaxed as they were not covered by the balloon protector.An examination of the balloon identified no issues which could potentially have contributed to this complaint.A visual examination identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.No other issues were identified during the product analysis.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 14804204
• MDR Text Key: 296183630
• Report Number: 2134265-2022-06916
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950020
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0026261505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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