MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT8 ASPIRATION CATHETER; DXE

Catalog Number	CAT8STR85
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital technologist inadvertently kinked an indigo system aspiration catheter 8 (cat8) while removing it from the packaging on the back table.The kinking of the cat8 occurred prior to use and therefore, the cat8 was not used in the procedure.The procedure was completed using a new cat8.
Additional Manufacturer Narrative
Correction to section: indigo system cat8 aspiration catheter.

• Brand Name: INDIGO SYSTEM CAT8 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7491797
• Report Number: 3005168196-2018-00940
• Device Sequence Number: 19210717
• Product Code: DXE
• UDI-Device Identifier: 00814548016269
• UDI-Public: 00814548016269
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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 Expiration Date: 07/04/2020
• Device Catalogue Number: CAT8STR85
• Device Lot Number: F78013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1