MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3825

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that a catheter and balloon had separated.A percutaneous coronary intervention was being performed and while pulling back on the 2.00mm x 12.00mm agent drug coated balloon catheter after dilation, the catheter and the balloon detached from one another and the balloon was stuck in the calcified lesion.Evacuation of the balloon was attempted by using another wire and distally placed balloon, however this attempt failed.The patient was sent to surgery for successful extraction of the balloon.The procedure was rescheduled for a later date.

Event Description

It was reported that a catheter and balloon had separated.A percutaneous coronary intervention was being performed and while pulling back on the 2.00mm x 12.00mm agent drug coated balloon catheter after dilation, the catheter and the balloon detached from one another and the balloon was stuck in the calcified lesion.Evacuation of the balloon was attempted by using another wire and distally placed balloon, however this attempt failed.The patient was sent to surgery for successful extraction of the balloon.The procedure was rescheduled for a later date.It was further reported the balloon and the shaft were inside patient and were removed during operation by the chirurg (surgeon).

Manufacturer Narrative

Device is a combination product.Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of an agent drug coated balloon.The tip, balloon and distal shaft was not returned for analysis.The device was bloody in the hub and the shaft.Microscopic and visual inspection of the device consisted of checking the device for damage along the shaft, hypotube and hub of the device.The hypotube was had kinks located 9.5 cm and 101 cm from the strain relief, and the shaft was completely separated and damaged (stretched) 108 cm from the hub.Inspection of the remainder of the device found no damage or irregularities.The reported separation/detachment was confirmed.

• Brand Name: AGENT
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8176339
• MDR Text Key: 130910025
• Report Number: 2134265-2018-64269
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2020
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 2546H18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/20/2019
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention