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

Catalog Number RBYPODJ45

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

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

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure using pod packing coils (pod pcs).During the procedure, the physician advanced a pod pc into the target vessel and decided to re-position the coil.While retracting the pod pc, it became stuck in its introducer sheath.Therefore, the pod pc was no longer used in the procedure.The procedure was completed using a new coil.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 distal tip was at the introducer sheath distal tip.The pull wire was in its initial position within the distal detachment tip (ddt), and the embolization coil¿s proximal constraint sphere was within the ddt.An unknown substance was within the introducer sheath distal tip.Conclusions: evaluation of the returned pod pc revealed that the embolization coil was detached from the pusher assembly and the proximal constraint sphere was within the pusher assembly ddt.If the pod pc is forcefully retracted against resistance, the stretch resistance wire (sr wire) within the embolization coil may fracture, causing the embolization coil to detach.The embolization coil was not returned for evaluation.Further evaluation revealed an unknown substance was within the introducer sheath distal tip.The unknown substance was likely incidental and may have occurred after removal of the device from the procedure.The root cause of the reported complaint could not be determined.Penumbra 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion of the root cause of pod packing coil becoming stuck in the introducer sheath h3 other text : placeholder.

Event Description

The patient was undergoing a coil embolization procedure using pod packing coils (pod pcs).During the procedure, the physician advanced a pod pc into the target vessel and decided to re-position the coil.While retracting the pod pc, resistance was encountered, and the coil became stuck in its introducer sheath.Therefore, the pod pc was no longer used in the procedure.The procedure was completed using a new coil of the same size.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 23 feb 22: 1.Section b.Box 5.Describe event or problem.

• Brand Name: POD PACKING COIL
• Type of Device: 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: 10635365
• MDR Text Key: 210005691
• Report Number: 3005168196-2020-01654
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,03/07/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F95482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/12/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 11/18/2020; 02/23/2022
• Supplement Dates FDA Received: 01/06/2021; 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male