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

Model Number RBYPODJ60-A

Device Problems Break (1069); Unraveled Material (1664)

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

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the duodenal artery using pod packing coils (pod pc) and a lantern delivery microcatheter (lantern).During the procedure, while retracting a pod pc through the lantern to reposition the pod pc, the pod pc broke and unraveled.Therefore, the pod pc was snared out.The procedure was completed using a new pod pc and the same lantern.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:3005168196-2020-02051 1.Section h.Box 6.Device code 2 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
• MDR Report Key: 10875945
• MDR Text Key: 217361851
• Report Number: 3005168196-2020-02051
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• Combination Product (y/n): Y
• PMA/PMN Number: K170852
• 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: 01/01/2005,10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPODJ60-A
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F98851
• Was Device Available for Evaluation?: No
• 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: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention