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

Catalog Number	RBYPOD8
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	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly and had offset coil winds.Resistance was encountered while attempting to advance the pod8 out of its introducer sheath and the pod8 could not be advanced any further.Conclusions: evaluation of the returned pod8 revealed that the embolization coil winds were offset inside it the introducer sheath.This type of damage typically occurs if the device is forcefully advanced against resistance.The root cause of resistance could not be determined.During the functional test, resistance was encountered while attempting to advance the pod8 and was unable to advance out of its introducer sheath.The offset coil winds likely contributed to the pod8 not being able to be advanced during the procedure and the function test during 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 using pod8s.During the procedure, the physician experienced resistance and was unable to advance a pod8 through its introducer sheath and into a lantern delivery microcatheter (lantern); therefore, it was removed.The procedure was completed using another pod8, ruby coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7878678
• Report Number: 3005168196-2018-01815
• Device Sequence Number: 16656472
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 08/16/2018
• 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: 10/01/2025
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F79795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• 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: 08/16/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 55
• Date Report Sent to FDA: 01/01/2005