MAUDE Adverse Event Report: PENUMBRA, INC. POD 6; HCG, KRD

Catalog Number	RBYPOD6
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/24/2019
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.This report is associated with mfr report number: 3005168196-2019-01130.
Event or Problem Description
During preparation for a coil embolization procedure, the physician advanced two pod6s into saline to check their shapes on the back table.However, while retracting the pod6s back into their introducer sheaths, both pod6s detached from their pusher assemblies.The damage to the pod6s occurred prior to use and, therefore, the pod6s were not used in the procedure.The procedure was completed using other pod packing coils.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 01 mfr report: 3005168196-2019-01131.Section h.Box 8.Usage of device.Results: the pet lock was damaged but intact and pull tube was retracted on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 90.0 and 109.0 cm from the proximal end.The embolization coil was detached from the pusher assembly ddt.Offset coil winds were present along the embolization coil.Conclusions: evaluation of the two returned pod6¿s revealed the pet lock on the proximal end of the pusher assemblies were damaged, the pull tubes were retracted, and the embolization coils were detached from the pusher assembly.If the devices are forcefully gripped or otherwise mishandled at extreme angles, the pet lock may become damaged and the pull tube may become retracted.If the pull tube retracts out of the pusher assembly ddt, the embolization coil will likely detach.Further evaluation of both devices revealed pusher assembly kinks and embolization coils with offset coil winds.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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: 3005168196-2019-01130.

• Brand Name: POD 6
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8688991
• Report Number: 3005168196-2019-01131
• Device Sequence Number: 3029738
• Product Code: HCG
• UDI-Device Identifier: 00814548013817
• UDI-Public: 00814548013817
• 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,Followup
• Report Date (Section B): 05/13/2019
• 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: 03/24/2026
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F82543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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