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

Model Number 7133

Device Problem Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or above.

Event Description

It was reported that catheter entrapment occurred.The 90% stenosed target lesion was located in the mildly calcified and mildly tortuous proximal left anterior descending artery.A 2.50mm x 15mm emerge balloon catheter was advanced to dilate the lesion.However, the balloon was entrapped with a non-boston scientific guidewire.Both devices were removed together within the catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.

Manufacturer Narrative

(a2) age at time of event: 18 years or above.Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was soaked in a water bath for three days to loosen the blood and contrast in the device.The device was functionally tested with a.014 inch guidewire.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported difficulties with the guidewire.

Event Description

It was reported that catheter entrapment occurred.The 90% stenosed target lesion was located in the mildly calcified and mildly tortuous proximal left anterior descending artery.A 2.50mm x 15mm emerge balloon catheter was advanced to dilate the lesion.However, the balloon was entrapped with a non-boston scientific guidewire.Both devices were removed together within the catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.

• 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: 11004534
• MDR Text Key: 221549199
• Report Number: 2134265-2020-17654
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806219
• UDI-Public: 08714729806219
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• 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: 03/02/2021

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: 08/09/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0024924836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 02/07/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1