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

Model Number	RBYPOD14-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was undergoing a coil embolization procedure using a pod coil, a lantern delivery microcatheter (lantern), and a neuron max 6f 088 long sheath (neuron max).It was reported that on (b)(6) 2020, the patient was treated for a pulmonary arteriovenous malformation (pavm) and resulted with the flow through the huge coil mass being ninety-five percent stagnant.However, on (b)(6) 2020, the physician reanalyzed the pavm and decided to place a pod coil behind the existing coil mass.During the procedure, while the physician attempted to place a pod coil behind the coil mass, the pod coil unintentionally detached with approximately forty centimeters of the pod coil remaining outside the coil mass.The physician then attempted to draw negative pressure on the lantern; however, it was unsuccessful.Then, the physician attempted to draw negative pressure while removing the lantern; however, it was also unsuccessful.Afterwards, the physician attempted to use a micro snare but was also unsuccessful.Lastly, the physician used an ensnare through the neuron max to remove the pod coil and was successful.The physician decided to end the procedure at this point.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11094831
• Report Number: 3005168196-2020-02383
• Device Sequence Number: 676297
• Product Code: HCG
• UDI-Device Identifier: 00814548019673
• UDI-Public: 00814548019673
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2026
• Device Model Number: RBYPOD14-A
• Device Catalogue Number: RBYPOD14
• Device Lot Number: F82531
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005