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

Model Number	CAT8XTORQ115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
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 superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8) and non-penumbra sheath.During the procedure, the physician completed two passes in the target vessel using the cat8 and sheath.While using the cat8 under aspiration on the third pass, the physician noticed that the hub of the cat8 had broken; therefore, it was removed.The procedure was completed using another cat8 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the cat8 was fractured approximately 2.0 cm from the hub.The device was kinked approximately 102.0 cm from the hub.Conclusions: evaluation of the returned cat8 confirmed a fracture near the hub.If the device is forcefully mishandled during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed a kink on the distal shaft.This damage was likely incidental to the reported complaint.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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9707929
• Report Number: 3005168196-2020-00192
• Device Sequence Number: 19668349
• Product Code: QEW
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 01/22/2020
• 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: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: CAT8XTORQ115
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: H10025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005