MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT8 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	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat8 was ovalized approximately 84.0 through 86.5 cm from the hub.The cat8 was damaged and, therefore, the cat8 could not be functionally tested.Conclusions: evaluation of the returned cat8 revealed that the distal shaft was ovalized.If the device is forcefully manipulated or gripped during insertion, damage such as ovalization may occur.The cat8 being inserted and removed from the sheath multiple times may have contributed to the device becoming ovalized.The non-penumbra sheath identified in the complaint was not returned to penumbra for evaluation.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 8 (cat8).During the procedure, the physician made multiple passes using the cat8 and a non-penumbra sheath.After at least four passes, the physician noticed that the tip of the cat8 had become flattened.Therefore, the physician used a new cat8 and the same sheath to complete the procedure.There was no report of an adverse effect to the patient.

• 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: 7916803
• Report Number: 3005168196-2018-01891
• Device Sequence Number: 2337729
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 08/29/2018
• 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: Health Professional
• Device Expiration Date: 01/03/2021
• Device Catalogue Number: CAT8TORQ85
• Device Lot Number: F81264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Date Report Sent to FDA: 01/01/2005