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

Catalog Number	RBYPOD8
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
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 pod8s.During the procedure, a pod8 unintentionally detached within a lantern delivery microcatheter (lantern).It was reported that the physician used a snare device to remove the detached pod8 from the patient.The procedure was then completed using a new pod8 and the same lantern.There was no report of an adverse effect to the patient.No further details were provided.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod8s.During the procedure, while advancing a pod8 through a lantern delivery microcatheter (lantern), the pod8 unintentionally detached within the lantern.Therefore, the physician removed the lantern containing the detached coil, removed the coil out and reinserted the lantern into the patient's body.The procedure was completed using a new pod8 and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 07/01/2019: section b.Box 1.Adverse event and/or product problem.Section b.Box 2.Outcomes attributed to adverse event.Section b.Box 5.Describe event or problem.Section d.Box 10.Device available for evaluation? section h.Box 1.Type of reportable event.Section h.Box 3.Device evaluated by manufacturer? section h.Box 3.Device returned to manufacturer? section h.Box 3.Reason for non-evaluation.Section h.Box 3.''other'' reason for non-evaluation.Section h.Box 6.Method codes 1-2.Section h.Box 6.Results code 1-4.Section h.Box 6.Conclusions code 1.Results: the proximal constraint sphere was intact on the proximal end of the embolization coil.Offset coil winds were present throughout the embolization coil.Conclusions: evaluation of the returned pod8 confirmed the embolization coil was detached.Evaluation revealed the proximal constraint sphere was intact with the embolization coil and offset coil winds were present.Embolization coil detachment typically occurs due to forceful retraction against resistance.The pod8 pusher assembly and the lantern identified in the complaint were not returned for evaluation; therefore, the root cause of the unintentional detachment could not be determined.If the pusher assembly is manipulated against resistance, offset coil winds may result.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: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8700847
• Report Number: 3005168196-2019-01170
• Device Sequence Number: 2207448
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 05/17/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2026
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F81545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/14/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005