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

Model Number 7172

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Event Description

It was reported that catheter entrapment occurred.The target lesion was located in a coronary vessel.A 1.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during advancing, the resistance with a non-bsc wire was severe and the device could not be advanced or pulled.It became stuck at the area before entering the guiding and the device was removed together with the non-bsc wire.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen, and blood in the guidewire lumen.The balloon was tightly folded, but the proximal end of the balloon was buckled.Microscopic inspection revealed tip damage.The shaft was buckled starting 3mm from the strain relief and extending distally for 31mm.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the difficulty advancing the guidewire.

Event Description

It was reported that catheter entrapment occurred.The target lesion was located in a coronary vessel.A 1.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during advancing, the resistance with a non-bsc wire was severe and the device could not be advanced or pulled.It became stuck at the area before entering the guiding and the device was removed together with the non-bsc wire.The procedure was completed with a diferent device.No patient complications were reported.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9203466
• MDR Text Key: 163161736
• Report Number: 2134265-2019-12248
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K083094
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: 7172
• Device Catalogue Number: 7172
• Device Lot Number: 0022185550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WIRE: ASAHI INTECC EXTENSION; WIRE: ASAHI INTECC EXTENSION