MAUDE Adverse Event Report: PENUMBRA, INC. POD 8; HCG, KRD

Catalog Number	RBYPOD8
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 coil embolization procedure in the splenic artery using pod packing coils (pod pcs) and a pod8.While removing a pod pc from its packaging hoop, the pusher wire became kinked.The pod pc was damaged prior to use and therefore, it was not used in the procedure.The physician then successfully placed six pod pcs in the target location using a non-penumbra microcatheter.Upon advancement of a pod8, the physician encountered resistance and decided to adjust the microcatheter and re-advance the pod8.When the physician had re-advanced the pod8 approximately halfway out of the microcatheter, the pusher wire kinked and broke and the pod8 unintentionally detached.The pod8 and microcatheter were then removed together from the patient and were no longer used in the procedure.The procedure was completed using a new microcatheter, a pod6, and pod pc.There was no report of an adverse effect to the patient.

• Brand Name: POD 8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9154373
• Report Number: 3005168196-2019-01858
• Device Sequence Number: 11370266
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K141134
• 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
• Report Date (Section B): 09/06/2019
• 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 Catalogue Number: RBYPOD8
• Device Lot Number: F88054
• Was Device Available for Evaluation?: No
• 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: 09/06/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005