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

Model Number	RBYPOD4-A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using pod coils and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician encountered resistance while advancing the first pod coil through its introducer sheath, and reported that it became stuck when the distal tip of the coil reached the distal tip of its introducer sheath.Therefore, the pod coil was removed.The procedure was completed using two ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod coil could not confirm that the embolization coil was stuck at the distal tip of its introducer sheath.Evaluation of the pod coil revealed offset coil winds on the proximal end of the embolization coil and throughout its length.If the device is forcefully manipulated against resistance during use, damage such as offset coil winds may occur.The root cause of resistance could not be determined.Further evaluation revealed a kink and bends throughout the length of the pusher assembly.This damage was incidental to the reported complaint.During the functional test, resistance was encountered due to the kink on the proximal end of the pusher assembly, while attempting to re-sheath the returned pod coil with a demonstration introducer sheath and no further testing could be performed.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.H3 other text : placeholder.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12186889
• Report Number: 3005168196-2021-01588
• Device Sequence Number: 19202480
• Product Code: HCG
• UDI-Device Identifier: 00814548019598
• UDI-Public: 00814548019598
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• 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): 07/30/2021
• 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 Model Number: RBYPOD4-A
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F102123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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