MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT5 ASPIRATION CATHETER; DXE

Catalog Number	CAT5
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat5 was fractured approximately 107.0 cm from the hub.Conclusions: evaluation of the returned device confirmed it was fractured.This damage may have occurred due to forceful withdrawal of the cat5 from the packaging at extreme angles.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a thrombectomy procedure using an indigo system cat5 aspiration catheter (cat5), the scrub technician removed the cat5 from the sterile package and noticed that the catheter was broken.The damage to the cat5 was found prior to use; therefore it was not used in the procedure.The procedure was completed using a new cat5.

• Brand Name: INDIGO SYSTEM CAT5 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7240827
• Report Number: 3005168196-2018-00238
• Device Sequence Number: 11021936
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2018

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: Radiologic Technologist
• Device Expiration Date: 02/16/2020
• Device Catalogue Number: CAT5
• Device Lot Number: F74471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1