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

Model Number RBYPODJ60-A

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

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 in the ovarian vein using pod packing coils (pod pcs).During the procedure, the hospital resident had kinked the pusher assembly of a pod pc while advancing the coil within the introducer sheath, and the pod pc detached.Therefore, the pod pc was removed.The procedure was completed using a new pod pc.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report:3005168196-2021-01970.1.Section h.Box 6.Device code 2.Evaluation of the returned pod pc confirmed that the pusher assembly was kinked in multiple locations throughout its length, and the embolization coil was detached.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, and pull wire was within ddt.If the pod pc forcefully advanced against resistance, damage such as a kink may occur.Subsequently, if the device is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching from the pusher assembly.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 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: 12436324
• MDR Text Key: 270264516
• Report Number: 3005168196-2021-01970
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/22/2021

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 Model Number: RBYPODJ60-A
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F106675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• 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: 08/11/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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