MAUDE Adverse Event Report: PENUMBRA, INC. POD8; HCG, KRD

Catalog Number	RBYPOD8
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
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 coil embolization procedure in the internal carotid artery (ica) using a pod8.During the procedure, the physician experienced resistance and the pod8 would not advance into the hub of a non-penumbra microcatheter; therefore, the pod8 was removed.The procedure was completed using another coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 92.0 cm from the proximal end.The introducer sheath was kinked and ovalized approximately 37.5, 76.0 and 113.0 cm from the proximal end.Conclusions: evaluation of the returned pod8 pusher assembly revealed a fracture and that the distal fractured portion of the pusher assembly and the embolization coil were not returned for evaluation; therefore, the reported complaint could not be confirmed.Further evaluation revealed kinks and ovalizations on the introducer sheath.The pusher assembly fracture and damage observed on the introducer sheath were not mentioned in the reported complaint and were likely incidental.Penumbra coils 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the reported resistance and failure to advance on pod8.H3 other text : placeholder.

• Brand Name: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8936814
• Report Number: 3005168196-2019-01642
• Device Sequence Number: 513734
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• 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): 07/30/2019
• 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: 09/13/2023
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F65687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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