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

Catalog Number	RBYPOD5
Medical Device Problem Codes	Failure to Fold (1255); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pod5 embolization coil was detached from its pusher assembly.The proximal constraint was intact with the rest of the embolization coil and the sr wire was undamaged.Conclusions: evaluation of the returned pod5 revealed that the embolization coil was detached from its pusher assembly.The pod5 pusher assembly was not returned for evaluation and, therefore, the root cause of the pod5 embolization coil detaching from its pusher assembly could not be determined.The non-penumbra microcatheter identified 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the epiglottis artery using pod5.During the procedure, the physician was unable to form the pod5 in the target location using a non-penumbra microcatheter; therefore, it was removed and saved for later use.The physician then placed three pods and penumbra coil 400s (pc400s) in the target vessel.Upon inspecting the shape of the initial pod5 outside of the patient¿s body, the pod5 detached.Therefore, the pod5 was not used in the procedure.The procedure was completed using a new pod5, penumbra smart coils, and additional coils with the same microcatheter.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: 8197737
• Report Number: 3005168196-2018-02528
• Device Sequence Number: 11161127
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K141134
• 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
• Report Date (Section B): 11/29/2018
• 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: 03/15/2024
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F68516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/26/2018
• 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