MAUDE Adverse Event Report: IMPERATIVE CARE INC TRACSTAR¿ LARGE DISTAL PLATFORM; PERCUTANEOUS CATHETER

Model Number	ICAC088105
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fistula (1862); Rupture (2208)
Date of Event	10/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported information does not suggest a device malfunction, and the manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occlusion in the m2/m3 segment of the middle cerebral artery (mca).The imperative care tracstar 088 ldp was used as the access catheter to support delivery of a penumbra 3max reperfusion catheter and a guidewire.All three devices were advanced to the cavernous segment of the internal carotid artery (ica), then the physician continued to advance the 3max and guidewire to the site of the occlusion.Aspiration was successfully performed using the 3max and it was removed from the patient.Subsequently, the physician decided to treat carotid atherosclerosis noted earlier in the procedure and pulled the tracstar back to perform a contrast imaging run.On the imaging run, the physician noted a carotid cavernous fistula (ccf) that wasn't present at the start of the procedure.As the tracstar, 3max, and guidewire were all advanced through the cavernous ica it is possible that one of these devices caused the ccf.The physician continued the procedure to treat the carotid atherosclerosis and decided that the ccf did not require immediate treatment as it was slow filling and asymptomatic.While the patient was asymptomatic following the procedure, a 30 day follow up cta was prescribed to monitor the ccf.

• Brand Name: TRACSTAR¿ LARGE DISTAL PLATFORM
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): IMPERATIVE CARE INC; 1359 dell ave; campbell CA 95008 6609
• MDR Report Key: 9345017
• Report Number: 3014590708-2019-00001
• Device Sequence Number: 16680641
• Product Code: DQY
• UDI-Device Identifier: 00812212030139
• UDI-Public: (01)00812212030139(17)200124(10)EPO072419-01
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/19/2019

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: 01/24/2020
• Device Model Number: ICAC088105
• Device Catalogue Number: ICAC088105
• Device Lot Number: EPO072419-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2019
• Initial Report FDA Received Date: 11/19/2019
• 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: Required Intervention
• Patient Age: 58 YR