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

Model Number	7134
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the 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.Inspection of the device presented numerous kinks throughout the hypotube with a complete hypotube break 49cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which indicates that the device was kinked prior to separation.An inflation device filled with water was connected to the remaining distal end of the device by attaching a toughy and a stopcock to the fractured hypotube.The device was inflated to the rated burst pressure for 5 minutes.The catheter maintained constant pressure and there was no indication of any leaks or other irregularities.
Event or Problem Description
Reportable based on device analysis completed on 20nov2019.It was reported that balloon leak and shaft kink occurred.A 2.50mm x 20mm emerge balloon catheter was selected for use.However, during preparation, it was noticed that the balloon catheter was kinked.When pressure was exerted, the balloon was found leaking gas.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed that balloon shaft was detached/separated.

• 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: 9416847
• Report Number: 2134265-2019-15050
• Device Sequence Number: 19455704
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: 11/22/2021
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0023554565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 69