MAUDE Adverse Event Report: IMPERATIVE CARE INC TRACSTAR LARGE DISTAL PLATFORM; CATHETER, PERCUTANEOUS, PRODUCT CODE: DQY

Model Number	ICAC088105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	04/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available for return as it was discarded; however the manufacturing records for this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing was completed to ensure the device is non-thrombogenic and in-process controls are established to minimize particulate and other surface defects that could impact thrombogenicity.At this time, the cause of the ica occlusion is unknown.If additional information is received, a supplemental report shall be issued.
Event or Problem Description
A thrombectomy was performed to treat occlusions in the left segment of the middle cerebral artery (mca).One occlusion was observed in the m1 mca, along with multiple occlusions within the m3 mca.The tracstar 088 ldp 105cm catheter was delivered over a guidewire and 027 microcatheter to the distal internal carotid artery (ica).The physician then advanced a reperfusion catheter and 3x20mm stent retriever through tracstar and used these devices to remove the clots from the m1 mca and m3 mca.Multiple attempts were required to remove all of the clots and the tracstar catheter was repositioned during these attempts.Reperfusion was achieved after over an hour of treatment with a final tici 2b score.Follow up mri performed the next day found a complete occlusion of the left carotid artery and a full hemispheric stroke that required treatment via a hemicraniectomy.The physician reviewed the final angiographic runs of the thrombectomy for potential causes of the occlusion and noted small microlesions in the ica, but saw no clear vessel dissection or injury that would have contributed to the event.At this time, the cause of the ica occlusion is unknown.

• Brand Name: TRACSTAR LARGE DISTAL PLATFORM
• Common Device Name: CATHETER, PERCUTANEOUS, PRODUCT CODE: DQY
• Manufacturer (Section D): IMPERATIVE CARE INC; 1359 dell avenue; campbell, ca
• MDR Report Key: 10054294
• Report Number: 3014590708-2020-00001
• Device Sequence Number: 14053528
• Product Code: DQY
• UDI-Device Identifier: 00812212030139
• UDI-Public: (01)00812212030139(17)210225(10)EPO022220-01
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2021
• Device Model Number: ICAC088105
• Device Catalogue Number: ICAC088105
• Device Lot Number: EPO022220-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening