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

Model Number 7134

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter with a 0.014" guidewire stuck in the device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple minor kinks along the hypotube.The guidewire that is stuck in the device extends approximately 148.3cm from the tip.Microscopic examination revealed buckling to the balloon, inflation lumen, and guidewire lumen.The buckling starts at approximately 4mm from the tip and is approximately 31mm long.The tip is damaged.Review of the product specification indicates a 0.014" guidewire is compatible with an emerge balloon catheter therefore, there is no indication of a compatibility issue.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that catheter entrapment occurred.The target lesion was located in the circumflex/obtuse marginal artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, it was noted that there was difficulty pulling the balloon over the wire.The device was removed together with the wire.The procedure was completed with another of the same 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
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8503758
• MDR Text Key: 141594323
• Report Number: 2134265-2019-03697
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: 08714729806301
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2021
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0023004627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• 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