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 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was received with balloon protector covering the balloon.The balloon protector was removed.There were no issues noted on the balloon that may have potentially contributed to the complaint incident during a visual and microscopic examination of the balloon material.A complete break was identified at the port bond.The device was returned in two separate sections.A visual and microscopic examination identified no issues with the extrusion shaft which could potentially have contributed to the break.Shaft break most likely occurred due to excessive force that could have been applied on the delivery system during preparation.A visual and tactile examination identified no kinks or damage.No other issues were identified during the product analysis.

Event Description

It was reported that the device fractured.The 100% stenosed target lesion was located at the moderately tortuous and mildly 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 hypotube part and catheter part were found to broken/separated when it was taken out from the hoop.The device was removed and replaced with another of the same device to complete the procedure.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9028551
• MDR Text Key: 158137409
• Report Number: 2134265-2019-11127
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2019

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: 01/10/2020
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0020144438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• 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