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

Model Number 24658

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified popliteal artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.Upon preparation, the proximal shaft separated during an attempt to remove the balloon cover.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

E1: initial reporter city - (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was returned with the balloon protector partially removed from the device.For investigation purposes the investigator fully removed the protector.A visual examination identified that the balloon was not subjected to positive pressure.The balloon material and blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were fully bonded to the balloon material.A microscopic examination identified that the shaft was completely detached at the shaft polymer extrusion to hypotube bond.This type of damage is consistent with excessive tensile force being applied when attempting to remove the balloon protector without applying a sufficient vacuum to the device.The device was received with the balloon protector partially removed from the device.The balloon protector's inner dimensions were verified and were within its specification.A visual and microscopic investigation identified no damage or any issues with the markerbands of the device that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the hypotube of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified popliteal artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.Upon preparation, the proximal shaft separated during an attempt to remove the balloon cover.The procedure was completed with a different device.No patient complications were reported.

• 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
• MDR Report Key: 9586676
• MDR Text Key: 178025979
• Report Number: 2134265-2019-16745
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0024206895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1