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

Catalog Number	RBYPOD5
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using pod coils and a non-penumbra microcatheter.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician successfully implanted three non-penumbra coils into the distal target site.After advancing a pod coil into the proximal target site, the physician reported that the coil would not take the desired shape.Therefore, the pod coil was removed.After flushing the microcatheter, the pod coil was re-inserted and became stuck in the middle of the microcatheter.While attempting to move the pod coil, resistance was encountered and the pod coil unintentionally detached inside the microcatheter when the distal end of the coil was in the middle of the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed from the patient.The procedure was completed using a non-penumbra coil and a new microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned pod5 confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pull wire was retracted out of the ddt.If this occurs, the embolization coil will detach from its pusher assembly.A demonstration coil was advanced through the non-penumbra microcatheter during evaluation without an issue.Therefore, the root cause of the returned pod coil getting stuck in the middle of the non-penumbra microcatheter during the procedure could not be determined.Penumbra products 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.H3 other text : placeholder.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14580252
• Report Number: 3005168196-2022-00251
• Device Sequence Number: 2238549
• Product Code: HCG
• UDI-Device Identifier: 00814548019604
• UDI-Public: 814548019604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022
• 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: RBYPOD5
• Device Lot Number: F108342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005