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

Catalog Number	RBYPOD8
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Premature Separation (4045)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pod8 was detached from the pusher assembly and the pull wire was retracted of its distal detachment tip (ddt).The pet lock on the proximal end of the pusher assembly showed signs of being compressed and retracted.The pod8¿s pusher assembly had kinks approximately 5.5 cm and 82.0 cm from the hub.The pod8 was detached from its pusher assembly and, therefore, the pod8 could not be functionally tested.Conclusions: evaluation of the returned pod8 revealed that the pull wire was retracted from the ddt and the embolization coil was detached.Further evaluation of the pet lock revealed it was compressed on the proximal end of the pusher assembly.If the device is forcefully handled during removal from the packaging hoop, damage such as this may occur.If the pet lock is compressed or broken during handling, it may allow the pull wire to retract from the ddt.Further evaluation of the returned pod8 also revealed that the pusher assembly was kinked.These kinks were likely incidental and may have occurred while packaging the device for return to penumbra.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 using a pod8.During the procedure, the hospital staff removed a pod8 from its packaging hoop and advanced the coil out of its introducer sheath outside of the patient.The physician then noticed that the pod8 had detached within the packaging hoop.The damage to the pod8 was found prior to use and, therefore, the pod8 was not used in the procedure.The procedure was completed using a new pod8.

• Brand Name: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7997474
• Report Number: 3005168196-2018-02094
• Device Sequence Number: 18882920
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 09/25/2018
• 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: 12/12/2025
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F81030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• 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: 09/25/2018
• Initial Report FDA Received Date: 10/23/2018
• 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