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

Model Number	RBYPOD6
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
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 coil embolization procedure in the gastroduodenal artery using a pod coil and a lantern delivery microcatheter (lantern).During the procedure, while advancing the pod coil through the lantern, the pod coil unintentionally detached inside the lantern.Therefore, the lantern containing the detached pod coil was removed and the pod coil was flushed out.The procedure was completed using a ruby coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal constraint sphere was intact on the proximal end of the embolization coil.Offset coil winds were present along the embolization coil.Conclusions: evaluation of the returned pod6 embolization coil confirmed it was detached from the pusher assembly and the pusher assembly was not returned.Further evaluation revealed offset coil winds along its length and the proximal constraint sphere was intact at its proximal end.The pod6 pusher assembly and the lantern used in the procedure were not returned for evaluation; therefore, the root cause of the unintentional detachment could not be determined.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the unintentional detachment.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.H3 other text : placeholder.

• Brand Name: POD COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9856876
• Report Number: 3005168196-2020-00405
• Device Sequence Number: 3432902
• Product Code: HCG
• UDI-Device Identifier: 00814548013817
• UDI-Public: 00814548013817
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 02/22/2020
• 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: 08/01/2026
• Device Model Number: RBYPOD6
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F85047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/22/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005