MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 3; DXE

Catalog Number	CAT3
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 3 (cat3).During the procedure, the physician had difficulty advancing an indigo system separator 3 (sep3) through the tip of the cat3 and noticed that the cat3 was kinked.The cat3 was removed from the patient and the procedure was completed using a new cat3 and the same sep3.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the indigo system cat3 aspiration catheter (cat3) was ovalized in multiple locations throughout its length, including 1.0 cm from the distal tip.Conclusion: evaluation of the returned device revealed it was ovalized in multiple locations throughout its length.This type of damage typically occurs due to improper handling during use.If the cat3 is forcefully compressed or pinched during removal from the packaging or insertion into the patient, damage such as this may occur.The sep3 mentioned in the complaint was not returned for evaluation.Penumbra catheters are 100% visually evaluated during in-process inspection.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 3
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5485934
• Report Number: 3005168196-2016-00291
• Device Sequence Number: 18938497
• Product Code: DXE
• UDI-Device Identifier: 00814548013299
• UDI-Public: 00814548013299
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2016

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: Physician
• Device Catalogue Number: CAT3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 03/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR