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

Model Number	RBYPOD6
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00954, 3005168196-2021-00956.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern), pod coils, and a non-penumbra sheath.It was noted that vascular access was slightly difficult.During the procedure, the physician introduced the lantern into the sheath to the target location.While advancing a few centimeters of a pod coil through the distal tip of the lantern, the physician experienced resistance and subsequently, the pod coil would not advance further.Therefore, the pod coil was removed.While attempting to advance a new pod coil, resistance was experienced; however, the physician was able to place the pod coil into the target vessel successfully.The physician then decided to remove the lantern due to the resistance.The procedure was completed using additional penumbra coils and a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod6 revealed offset coil winds in its embolization coil.If the device is forcefully advance against resistance, damage such as this may occur.The resistance likely occurred due to the damaged lantern used in the procedure.Further evaluation of the device revealed pusher assembly kink.This damage was incidental to the reported complaint.Penumbra catheters 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: 1.3005168196-2021-00954.2.3005168196-2021-00956.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11773600
• Report Number: 3005168196-2021-00955
• Device Sequence Number: 3778599
• Product Code: HCG
• UDI-Device Identifier: 00814548013817
• UDI-Public: 00814548013817
• 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,Followup
• Report Date (Section B): 04/13/2021
• 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 Expiration Date: 11/15/2024
• Device Model Number: RBYPOD6
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F72119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005