MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Catalog Number	RBYPOD5
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pod5 pusher assembly was kinked.Conclusions: evaluation of the returned pod5 revealed that the pusher assembly was kinked.This damage was likely incidental and may have occurred from packaging the device for return to penumbra.Due to the returned condition of the pod5, the device could not be functionally tested.Therefore, the root cause of the reported difficulty advancing could not be determined.The lantern referred to in the complaint was not returned for evaluation.Penumbra coils are visually 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 numbers: 3005168196-2018-00454.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a large varicocele using ruby coils and a pod5.During the procedure, prior to use, a ruby coil pusher assembly became kinked while being removed from the dispenser hoop; therefore it was set aside and the procedure continued with other coils.The physician then had difficulty advancing a pod5 into the existing coil mass in the varicocele due to the fact that the pod5 was the wrong size; therefore, it was removed.The procedure was successfully completed using other ruby coils and the same lantern delivery microcatheter (lantern).There was no report of an adverse effect to the patient.

• Brand Name: POD5
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7307935
• Report Number: 3005168196-2018-00455
• Device Sequence Number: 11324880
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 02/06/2018

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: Physician
• Device Expiration Date: 12/06/2024
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F72970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR