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

Catalog Number	RBYPODJ15
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
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 the aortopulmonary collaterals using a lantern delivery microcatheter (lantern), pod packing coils (pod pc), ruby coil lps, ruby coils, and a non-penumbra diagnostic catheter.During the procedure, the physician attempted to advance the lantern into the diagnostic catheter; however, the physician experienced resistance and the lantern would not advance more than few millimeters into the diagnostic catheter.Therefore, the lantern was removed and a non-penumbra microcatheter was advanced through the diagnostic catheter.The physician then placed a few ruby coils in the target location.Next, the physician advanced the pod pc into the target location; however, while attempting to reposition the pod pc, the pod pc unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached pod pc was removed and the pod pc was flushed out on the back table.The physician then used the same microcatheter and placed another pod pc successfully.The physician then used another non-penumbra microcatheter to advance the ruby coil lps.While attempting to advance the ruby coil lp into the microcatheter, the ruby coil lp would not advance past its initial position within its introducer sheath.The physician then removed the ruby coil lp and attempted to advance the ruby coil lp on the back table; however, the ruby coil lp still would not advance past its initial position.Therefore, the ruby coil lp was not used.The procedure was completed using a new ruby coil lp, the same microcatheter and the same diagnostic catheter.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16971072
• Report Number: 3005168196-2023-00236
• Device Sequence Number: 5392746
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 814548017648
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2023
• 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: RBYPODJ15
• Device Lot Number: F00005672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 04/28/2023
• Initial Report FDA Received Date: 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005