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

Model Number RBYPOD8-A

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2020

Event Type  malfunction  

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 Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a pod coil and a lantern delivery microcatheter (lantern).During the procedure, the physician encountered resistance while attempting to insert a pod coil into the lantern and the pusher assembly of the pod coil broke; therefore, the pod coil was removed.The procedure was completed using a new pod coil and the same lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 75.5 cm from its proximal end.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly.The introducer sheath was ovalized approximately 3.0 cm from the distal tip.Conclusions: evaluation of the returned pod coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock, and the distal tip of the introducer sheath was ovalized.This damage was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Due to the returned damage, the functional testing could not be performed; therefore, the root cause of the reported complaint could not be determined.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.

• Brand Name: POD
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10621192
• MDR Text Key: 209623550
• Report Number: 3005168196-2020-01633
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019635
• UDI-Public: 00814548019635
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPOD8-A
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F85281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR