MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 ASPIRATION CATHETER; DXE

Catalog Number	CAT8TORQ85
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femoral artery using an indigo system cat8 aspiration catheter (cat8).During the procedure, the physician made one pass within a non-penumbra sheath, and then removed the cat8 to flush it.Upon removal, the physician noticed that the tip of the cat8 was deformed.The cat8 was therefore not reused, and the procedure was completed using a new cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the cat8 was fractured approximately 86.0 cm from the hub.The cat8 was damaged and therefore, could not be functionally tested.Conclusions: evaluation of the returned cat8 revealed that the distal tip of fractured.This type of damage typically occurs during removal of the device from the packaging.If the packaging mandrel is unsecured it may slip into the packaging tube.This may cause the distal tip of the cat8 to become pinned between the mandrel and packaging tube.If the cat8 is subsequently retracting, the distal atraumatic tip may become damaged.Penumbra catheters are visually 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.

• Brand Name: INDIGO SYSTEM CAT 8 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7433234
• Report Number: 3005168196-2018-00764
• Device Sequence Number: 18860084
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018
• Report Date (Section F): 01/01/2005

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 Expiration Date: 04/11/2020
• Device Catalogue Number: CAT8TORQ85
• Device Lot Number: F75572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005