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

Model Number 7134

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.At 81cm from the strain relief the hypotube was kinked.At 85.2cm from the strain relief there was separation of the hypotube.The distal portion of the separation there was a shaft kink at 46.6cm.There were kinks in the shaft on both ends of the proximal markerband in the balloon.There was proximal markerband damage.There was contrast present in the inflation lumen and the balloon was tightly folded.

Event Description

Reportable based on device analysis completed on 02-jul-2021.It was reported that shaft kink occurred.The 80% stenosed target lesion was located in the proximal part of left anterior descending artery.A 2.50mm x 20mm emerge balloon catheter was selected for use.However, during preparation, it was found out that the connecting part of the balloon was kinked.The procedure was completed with another of same device.No patient complications were reported and the patient status is stable.However, device analysis revealed markerband damage and hypotube break.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12214833
• MDR Text Key: 263097029
• Report Number: 2134265-2021-09460
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2022
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0025209665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• 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
• Patient Age: 70 YR
• Patient Weight: 80