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

Model Number	7134
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12214833
• Report Number: 2134265-2021-09460
• Device Sequence Number: 4672379
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 80