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

Model Number	RBYPOD14-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
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 internal iliac artery (iia) using pod coils, a lantern delivery microcatheter (lantern), and a non-penumbra catheter.During the procedure, the physician encountered resistance while advancing the pod coil through the lantern.The physician tried to advance the pod coil through the lantern again and encountered more resistance.Therefore, the lantern and pod coil were removed together from the patient.After removal, while the devices were on the back table, the physician realized the pod coil had detached inside the lantern.Subsequently, the pod coil was removed from the lantern.The procedure was completed using the same lantern, another pod coil, and three non-penumbra coils.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 pusher assembly.The pusher assembly was kinked approximately 5.0 cm, 37.0 cm and 70.0 cm from the proximal end.The pusher assembly was fractured approximately 72.0 cm from the proximal end.The distal segment of the fractured pusher assembly was not returned for evaluation.The embolization coil was detached from the pusher assembly.The proximal constraint sphere was intact with the embolization coil and the embolization coil was undamaged.Conclusions: evaluation of the returned pod coil confirmed a detached embolization coil and revealed a fractured pusher assembly.If the device is forcefully advanced against resistance, the pusher assembly may become kinked and subsequently a fracture may occur.This pusher assembly fracture likely contributed to the reported embolization coil detachment during the procedure.The distal segment of the fractured pusher assembly was not returned for evaluation.Due to the pusher assembly fracture, the functional testing was unable to be performed; therefore, the root cause of the resistance experienced during the procedure could not be determined.Further evaluation of the device revealed kinks on the pusher assembly and these kinks were likely incidental to the complaint.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.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10580037
• Report Number: 3005168196-2020-01552
• Device Sequence Number: 2627896
• Product Code: HCG
• UDI-Device Identifier: 00814548019673
• UDI-Public: 00814548019673
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020
• 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 Model Number: RBYPOD14-A
• Device Catalogue Number: RBYPOD14
• Device Lot Number: F86844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005