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

Catalog Number	RBYPODJ30
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
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.This report is associated with mfr report number: 3005168196-2020-02094.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (pavm) using pod packing coils (podjs), ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed a ruby coil into the target location using the lantern.Then, the physician placed a podj (f94195) into the target location using the lantern and when checking the density via an angiography, everything was great.Three minutes later, while successfully placing another ruby coil into the vein, it was seen via an angiography that the previous podj that was placed was getting a bit loose making a small loop proximal.Subsequently, a few minutes later, the proximal end of the podj loosened more.The physician then placed another ruby coil into the target location using the lantern.Then, while advancing another podj (f97197), the podj unintentionally detached and subsequently, the physician was unable to manipulate the podj to reach the target location.Therefore, the physician removed the pusher assembly and attempted to push the podj using a non-penumbra guidewire into the target location with limited success.It was reported that the proximal end of the podj migrated in the artery; however, it was reported that the desired density was achieved.The physician decided to leave the podj in the artery the podj migrated to.The procedure was completed using two additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10906704
• Report Number: 3005168196-2020-02095
• Device Sequence Number: 13741626
• Product Code: HCG
• UDI-Device Identifier: 00814548016719
• UDI-Public: 00814548016719
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F97197
• 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: 10/29/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 70
• Date Report Sent to FDA: 01/01/2005