MAUDE Adverse Event Report: PENUMBRA, INC. POD12; HCG, KRD

Catalog Number	RBYPOD12
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2019-01238, 3005168196-2019-01240.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a pod8 and a pod12.During the procedure, the physician experienced resistance when using the pod8 and the pod12 and was unable to advance either coil through the lantern delivery microcatheter (lantern).The coils were therefore removed and were not used in the procedure.There was no report of an adverse effect to the patient.No further information is available.
Additional Manufacturer Narrative
Results: the proximal constraint sphere was intact on the proximal end of the embolization coil.Minor offset coil winds were present on the embolization coil.Conclusions: evaluation of the returned pod8 revealed a functional device.During functional testing, the pod8 was advanced through a demonstration catheter with resistance.Further evaluation revealed pusher assembly kinks and an embolization coil with offset coil winds.These damages were not mentioned in the reported complaint and were likely incidental and may have occurred during packaging for return to penumbra.Evaluation of the returned pod12 embolization coil revealed offset coil winds.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.The pusher assembly was not returned for evaluation the lantern identified in the reported complaint was not returned for evaluation; therefore, the root cause of the inability to advance the two returned coils through the lantern could not be determined.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 numbers: 3005168196-2019-01238 and 3005168196-2019-01240.

• Brand Name: POD12
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8739821
• Report Number: 3005168196-2019-01239
• Device Sequence Number: 11404495
• Product Code: HCG
• UDI-Device Identifier: 00814548019666
• UDI-Public: 00814548019666
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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,Followup
• Report Date (Section B): 05/28/2019
• 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 Catalogue Number: RBYPOD12
• Device Lot Number: F86501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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