MAUDE Adverse Event Report: ASAHI INTECC ASTATO; WIRE, GUIDE, CATHETER

Model Number	171406
Health Effect - Clinical Codes	Intimal Dissection (1333); Calcium Deposits/Calcification (1758)
Date of Event	08/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure note: once we had set up completed using a.035" navi-cross and a.014" command wire initial attempt to cross the lesion in the proximal was unsuccessful.This was then exchanged for a wire, which was able to be advanced, but it was at this point subintimal.At this point, using a combinations of a command wire, winn wire, astato wire, and a glide advantage wire, we tried to get back in the true lumin which was unsuccessful.We attempted looping the wire with the neck, but that was also successful.After some period of time we elected to see if we could try a reentry device.As we got down to the distal sfa, at this point where we were able to create a reentry site, i was able to get my wire to go back luminal.The navicross was advanced and 3cc injection confirmed intraluminal course.The wound wire was then exchanged for a command wire again.The navicross was removed and attempt to advance was unsuccessful due to the significant of the lesions in the intimal tract.We then went in with a 1.5 x 150 mm armada balloon.It was able to be advanced and balloon inflation was performed from the distal to the ostium.The 2 x 200 mm armada balloon was also easily advanced into the distal to the ostium and balloon inflations performed.The inflations were done at nominal pressures for about one to two minutes.At this point the distal lesion appeared to be about 4.5mm, but wanted to confirm it.We used the ivis for evaluation of the size.A volcano eagle eye was advanced into the distal and retrograde pullback.Measurements were performed showed the distal to be about 5mm in the ostium; the proximal sfa was about 5.2 mm.There is moderate amount of calcification throughout the course of the sfa.Next we went with a 5 x 150 mm balloon and further dilated the vessel in preparation for stent deployment.Next using a 4.5 x 120 mm superior stent was deployed from distal to mid.This was then overlapped to the second 5 oh by 100 mm superior stent.Finally, a 5x80 mm was used for the proximal segment.The ostium was not stented, but was dilated further with a 5 x 60 mm armada balloon.There is a small linear dissection in the very proximal ostium segment, but is not flow-limiting.We elected to not do further stenting.Patient had timi 3 flow down the ostium.There was 100 %disease in the mid popliteal, but had good collaterals.At this point the lesion was fairly focal.Elected to see how the patient will respond with the inflow treatment prior to further embarking on treating the 100 percent popliteal lesion, which is fairly short with good collaterals.Of note during the attempt to get back intraluminal, a starter wire tip was sheared off in the subintimal plane.This was secured with the stent deployment at that segment.
Event or Problem Description
Procedure note: once we had set up completed using a.035" navi-cross and a.014" command wire initial attempt to cross the lesion in the proximal was unsuccessful.This was then exchanged for a wire, which was able to be advanced, but it was at this point subintimal.At this point, using a combinations of a command wire, winn wire, astato wire, and a glide advantage wire, we tried to get back in the true lumin which was unsuccessful.We attempted looping the wire with the neck, but that was also successful.After some period of time we elected to see if we could try a reentry device.As we got down to the distal sfa, at this point where we were able to create a reentry site, i was able to get my wire to go back luminal.The navicross was advanced and 3cc injection confirmed intraluminal course.The wound wire was then exchanged for a command wire again.The navicross was removed and attempt to advance was unsuccessful due to the significant of the lesions in the intimal tract.We then went in with a 1.5 x 150 mm armada balloon.It was able to be advanced and balloon inflation was performed from the distal to the ostium.The 2 x 200 mm armada balloon was also easily advanced into the distal to the ostium and balloon inflations performed.The inflations were done at nominal pressures for about one to two minutes.At this point the distal lesion appeared to be about 4.5mm, but wanted to confirm it.We used the ivis for evaluation of the size.A volcano eagle eye was advanced into the distal and retrograde pullback.Measurements were performed showed the distal to be about 5mm in the ostium; the proximal sfa was about 5.2 mm.There is moderate amount of calcification throughout the course of the sfa.Next we went with a 5 x 150 mm balloon and further dilated the vessel in preparation for stent deployment.Next using a 4.5 x 120 mm superior stent was deployed from distal to mid.This was then overlapped to the second 5 oh by 100 mm superior stent.Finally, a 5x80 mm was used for the proximal segment.The ostium was not stented, but was dilated further with a 5 x 60 mm armada balloon.There is a small linear dissection in the very proximal ostium segment, but is not flow-limiting.We elected to not do further stenting.Patient had timi 3 flow down the ostium.There was 100 %disease in the mid popliteal, but had good collaterals.At this point the lesion was fairly focal.Elected to see how the patient will respond with the inflow treatment prior to further embarking on treating the 100 percent popliteal lesion, which is fairly short with good collaterals.Of note during the attempt to get back intraluminal, a starter wire tip was sheared off in the subintimal plane.This was secured with the stent deployment at that segment.

• Brand Name: ASTATO
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-chi; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9137705
• Report Number: 3004718255-2019-00118
• Device Sequence Number: 2509306
• Product Code: DQX
• UDI-Device Identifier: 04547327088305
• UDI-Public: (01)04547327088305(17)211031(10)181119A181
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019
• Report Date (Section F): 02/13/2020

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 Model Number: 171406
• Device Lot Number: 1811119A81
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 02/13/2020