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

Catalog Number	RBYPOD5
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	06/07/2019
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 number: 3005168196-2019-01312.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod5 and a lantern delivery microcatheter (lantern).It was noted that the patient's anatomy was extremely tortuous.During the procedure, while advancing the pod5 through the lantern, the physician experienced resistance and subsequently, the pod5 became stuck and would not exit the tip of the lantern.Therefore, the physician detached the pod5 using a pod coil detachment handle (handle) within the lantern and attempted to flush it; however, the pod5 did not move.Therefore, the lantern and pod5 were removed together.The procedure was completed using other coils and another microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pod5 embolization coil was within the lantern.The embolization coil had offset coil winds on the proximal end.Conclusions: evaluation of the returned lantern revealed the distal tip was ovalized.If the lantern is forcefully gripped or pinched during preparation, damage such as an ovalization may occur.The reported tortuous anatomy may have contributed to the damage on the lantern.Evaluation of the pod5 revealed an embolization coil with offset coil winds.If the pod5 is forcefully advanced against resistance, damage such this may occur.Further evaluation revealed the pod5 was stuck inside the returned lantern at the site of the ovalization and could not be removed.The ovalization on the lantern likely contributed to the resistance experienced during the procedure and the damage to the pod5.The pusher assembly of the pod5 was not returned for evaluation.Penumbra catheters and 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: 1.(b)(4).H3 other text : placeholder.

• Brand Name: POD5
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8761180
• Report Number: 3005168196-2019-01313
• Device Sequence Number: 16564122
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/07/2019
• 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: 07/30/2025
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F78455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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