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

Model Number	RBYPODJ5-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a branch of the pulmonary artery using pod packing coils (pod pcs).It was reported the patient had a previous embolization procedure.During the procedure, the physician implanted one pod pc in the target location.Subsequently, the physician attempted to use another pod pc (f100414) and bent the pusher assembly.The pod pc was then removed.Next, the physician opened another pod pc (c11947).The lantern was not staying in the pulmonary artery branch and was unable to advance back into the target location when the physician attempted to advance the pod pc.The pod pc was then removed, and the physician decided not to use additional coils.There was no flow through the coil, and the physician was satisfied.The procedure ended at this point.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: 11868214
• Report Number: 3005168196-2021-01136
• Device Sequence Number: 11678279
• Product Code: HCG
• UDI-Device Identifier: 00814548017631
• UDI-Public: 00814548017631
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• 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): 04/26/2021
• 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 Model Number: RBYPODJ5-A
• Device Catalogue Number: RBYPODJ5
• Device Lot Number: F100414
• 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: 04/26/2021
• Initial Report FDA Received Date: 05/22/2021
• 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
• Date Report Sent to FDA: 01/01/2005