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

Catalog Number	RBYPODJ60
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
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: 1.3005168196-2020-01541.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ovarian vein using lantern delivery microcatheters (lantern), and pod packing coils (podj).During the procedure, while attempting to rotate the lantern from the left renal vein into the left ovarian vein, the lantern broke approximately fifteen centimeters from the hub.Therefore, the lantern was pulled out.The physician then placed three ruby coils, and two podjs into the target vessel using a new lantern.Next, the physician advanced another podj into the target vessel, and determined that it was too long.Therefore, the physician decided to remove the podj.While retracting the podj, it became stuck at the distal end of the lantern and subsequently, unintentionally, detached within the lantern.Therefore, the lantern containing the detached podj was removed and the podj was flushed out.The procedure was completed using a new podj and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report: 3005168196-2020-01542.This report is associated with mfr report number: 1.3005168196-2020-01541.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ovarian vein using a lantern delivery microcatheters (lantern) and pod packing coils (podj).During the procedure, while attempting to rotate the lantern from the left renal vein into the left ovarian vein, the lantern broke approximately fifteen centimeters from the proximal hub outside the patient''s body.Therefore, the lantern was pulled out.The physician then placed three ruby coils and two podjs into the target vessel using a new lantern.Next, the physician advanced another podj into the target vessel and determined that it was too long; therefore, the physician decided to remove the podj.While retracting the podj, it became stuck at the distal end of the lantern and subsequently, unintentionally detached within the lantern.Therefore, the lantern containing the detached podj was removed and the podj was flushed out.The procedure was completed using a new podj 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: 10560528
• Report Number: 3005168196-2020-01542
• Device Sequence Number: 11549286
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 08/26/2020
• 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: RBYPODJ60
• Device Lot Number: F97914
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005