MAUDE Adverse Event Report: PENUMBRA, INC. POD4; HCG, KRD

Model Number	RBYPOD4
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01453.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod4s and pod8s.During the procedure, the physician advanced a guidewire to the target vessel through a non-penumbra microcatheter.While advancing a pod4 through the microcatheter to the target vessel, the pod4 would not easily advance; therefore, the pod4 was removed.After that, the physician successfully placed new pod4s, ruby coils and pod packing coils (pod pc) in the target vessel.While advancing a pod8 through the microcatheter, the same occurred as the initial pod4; therefore, the pod8 was removed.The procedure was completed using other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2019-01453.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod4s, pod8s, ruby coils, pod packing coils (pod pc), a non-penumbra guide catheter, and a non-penumbra microcatheter.During the procedure, while advancing a pod4 through the microcatheter to the target vessel, the physician experienced resistance and the pod4 would not easily advance; therefore, the pod4 was removed.After that, the physician successfully placed new pod4s, ruby coils, and pod pcs.While advancing a pod8 through the microcatheter, the same issue occurred; therefore, the pod8 was removed.The procedure was completed using other penumbra coils with the same guide catheter and microcatheter.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 pod4 pusher assembly.The pusher assembly was kinked approximately 5.0, 70.0, 72.0, 72.5, 99.5, 132.0 and 134.0 cm from the proximal end.The introducer sheath was loaded backwards onto the pod4.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present throughout the embolization coil.Conclusions: evaluation of the returned pod4 revealed a functional device and the introducer sheath was loaded onto the pod4 backwards.During functional testing, the introducer sheath was removed and the pod4 was re-sheathed correctly.The pod4 was then advanced out of its introducer sheath and through a demonstration microcatheter with resistance.Further evaluation revealed pusher assembly kinks and offset coil winds along the embolization coil.These damages may have contributed to the resistance experienced during the functional testing.The observed damages were not mentioned in the reported complaint and were likely incidental and may have occurred during packaging for return to penumbra.Evaluation of the returned pod8 revealed an undamaged, functional device.The introducer sheath associated with the pod8 was not returned for evaluation; therefore, the pod8 was re-sheathed with a demonstration introducer sheath during functional testing.The pod8 was then advanced out of the introducer sheath and then through a demonstration microcatheter without an issue.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance experienced during the procedure could not be determined.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.This report is associated with mfr report number: 3005168196-2019-01453.

• Brand Name: POD4
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8827224
• Report Number: 3005168196-2019-01452
• Device Sequence Number: 2860255
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 09/24/2021
• 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: 03/30/2024
• Device Model Number: RBYPOD4
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F68771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/05/2019; 09/24/2021
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 09/05/2019; 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005