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

Model Number	7135
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in a left coronary artery.After a 300cm non-bsc support guidewire crossed the lesion, a 4.00mm x 30mm emerge balloon catheter was advanced for dilatation.However, during withdrawal, the balloon could not move without moving the wire.The procedure was completed with a different device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in a left coronary artery.After a 300cm non-bsc support guidewire crossed the lesion, a 4.00mm x 30mm emerge balloon catheter was advanced for dilatation.However, during withdrawal, the balloon could not move without moving the wire.The procedure was completed with a different device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
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 a complete separation at 119cm distal of the strain relief.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.There were pinholes 1mm proximal of the proximal marker band, at the proximal marker band, and 2mm, 4mm, 6mm, and 8 mm distal of the proximal marker band.The inner shaft was buckled 14cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 9889520
• Report Number: 2134265-2020-03780
• Device Sequence Number: 2240098
• Product Code: LOX
• UDI-Device Identifier: 08714729806479
• UDI-Public: 08714729806479
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 09/10/2021
• Device Model Number: 7135
• Device Catalogue Number: 7135
• Device Lot Number: 0023180988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: WHISPER EXTRA SUPPORT 300CM; GUIDEWIRE: WHISPER EXTRA SUPPORT 300CM