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	02/04/2021
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 the subclavian artery to treat a leak on the previously placed amplatzer plug using pod packing coils (podjs), a lantern delivery microcatheter (lantern), a non-penumbra diagnostic catheter and a sheath.During the procedure, the physician placed a podj on top of the amplatzer plug using the lantern.The physician then placed another podj in the target location and decided to retract the podj to reposition.While retracting the podj, the physician experienced resistance and the podj unintentionally detached inside the lantern.The physician then removed the lantern containing the detached podj and noticed that part of the podj was in the vessel and the other part of the podj was in the diagnostic catheter.Upon removal of the diagnostic catheter, the physician noticed that part of the podj was in the vessel and the other part of the podj was in the sheath.Subsequently, the podj broke into two pieces; therefore, the physician pulled the broken podj from the sheath.The physician then placed additional podjs in the target location using the lantern.While advancing another podj through the lantern, the podj became stuck at the distal end of the lantern.While retracting the podj, the physician experienced resistance and subsequently, the podj broke into two pieces.Therefore, the physician removed the lantern containing the detached podj and then removed the diagnostic catheter.The procedure was completed using other coils, a new lantern, and a new diagnostic catheter.It was also reported that during the procedure, the diagnostic catheter was replaced two times; however, it is unknown at what point during the procedure that occurred.There was no 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: 11404765
• Report Number: 3005168196-2021-00390
• Device Sequence Number: 20023634
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• 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): 02/04/2021
• 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 Catalogue Number: RBYPODJ60
• Device Lot Number: F98303
• 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: 02/04/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005