MAUDE Adverse Event Report: PENUMBRA, INC. POD6; HCG, KRD

Catalog Number	RBYPOD6
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	08/30/2019
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 subclavian artery using a pod6.During the procedure, while attempting to implant the pod6 in the target vessel using a non-penumbra microcatheter, the pod6 was not placed in the desired position; therefore, the physician re-sheathed the pod6 in order to re-position it.While re-advancing the pod6 through the microcatheter, the physician experienced resistance after advancing approximately 1/3 of the pod6 into the microcatheter and realized that the pod6 pusher assembly was kinked.Subsequently, the pod6 unintentionally detached with approximately 2/3 of the pod6 still within the introducer sheath.Therefore, the physician removed the introducer sheath with the detached pod6 from the hub of the microcatheter.The procedure was completed using four ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: POD6
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9126651
• Report Number: 3005168196-2019-01830
• Device Sequence Number: 16727752
• Product Code: HCG
• UDI-Device Identifier: 00814548013817
• UDI-Public: 00814548013817
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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): 08/30/2019
• 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: 04/12/2025
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F75633
• 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: 08/30/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/01/2005