MAUDE Adverse Event Report: TERUMO CLINICAL SUPPLY CO., LTD. PRIORITYONE ASPIRATION CATHETER; CATHETER, EMBOLECTOMY

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned for evaluation, only images were provided.According to the observation of image, we confirmed a tore at the of the exit port heading for the front end side.We performed simulation test by using new aspiration catheter equivalent to priority one ac and ptca trainer.We set the fit size guide wire to the aspiration catheter, and inserted to ptca trainer with fit size guiding catheter.The tore at the exit port in the involved product occurred by a removal operation that was performed in the state of bending the guidewire used together.Guidewire bent nearby the exit port , which resulted in resistance.By pulling the catheter while the guidewire was bent, corruption of exit port occurs.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.We investigated the complaint records of the lot 181202030, and we found no same kinds of complaints were reported in the past.This report is for the second device used on the patient.For the first device reported on the same patient, see mdr 3009500972-2020-00001.(b)(4).
Event or Problem Description
The user facility reported that we loaded the catheter (with the stylet) over the coronary wire.Then, removed stylet and hooked up to the negative syringe.As we pulled back, the wire started to come back and felt stuck so we pulled it all out and the wire was kinked at the proximal port.We rewired and tried another catheter in the same way and it happened again.The patient condition was good.The procedure outcome was ok.Additional information was received (b)(6) 2020: the procedure was a stemi and this event occurred as the doctor attempted to do aspiration thrombectomy.

• Brand Name: PRIORITYONE ASPIRATION CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehaya-machi; kakamigahara,; gifu, 501-6 024,; JA 501-6024,
• MDR Report Key: 9661412
• Report Number: 3009500972-2020-00002
• Device Sequence Number: 14181188
• Product Code: DXE
• UDI-Device Identifier: 04543334177254
• UDI-Public: 04543334177254
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 30-6100
• Device Lot Number: 181202030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1