MAUDE Adverse Event Report: CORDIS CORPORATION 8MM BASKET, MEDIUM SUPPORT,; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number	801814RMC
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The angioguard filter was deployed in a normal fashion; however, during the retrieval portion, the physician could not get the filter to collapse into retrieval sheath.The filter was removed while being partially collapsed as it would not collapse completely.At the time of the procedure, there were no signs of an adverse event or complications to the patient.The product was not returned for analysis.No lot number was provided therefore a device history record (dhr) review could not be generated.The reported ¿capture system capture difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown.As no lot number was supplied a dhr could not be completed.The filter membrane is not designed to fully collapse to enable possible debris to remain in the filter and be removed.According to the instructions for use ¿when the capture sheath¿s distal radiopaque marker band and the basket¿s proximal marker band touch, the basket is captured.The filter membrane is not captured by the sheath.After the capture sheath is in position, using fluoroscopy, confirm filter basket closure by ensuring reduction of the filter basket diameter shown by the radiopaque strut markers, keeping in mind that the emboli that have been captured may not allow the angioguard xp emboli capture guidewire to reach its initial low profile.¿ the information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
It was reported that the angioguard filter was deployed in a normal fashion, however, during the retrieval portion, the physician could not get the filter to collapse into retrieval sheath.The filter was removed while being partially collapse as it would not collapse completely. at the time of the procedure, there were no signs of an adverse event or complications to the patient.

• Brand Name: 8MM BASKET, MEDIUM SUPPORT,
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 6593932
• Report Number: 1016427-2017-00309
• Device Sequence Number: 10843849
• Product Code: NTE
• UDI-Device Identifier: 20705032056943
• UDI-Public: 20705032056943
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K062531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2017

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: 801814RMC
• Device Catalogue Number: 801814RMC
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1