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

Catalog Number RBYPODJ30

Device Problem Premature Separation (4045)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2023

Event Type  Injury  

Event Description

The patient was undergoing a stent-assisted coiling procedure in the left renal artery using a pod packing coil (podj), a non-penumbra microcatheter, a non-penumbra sheath, and a stent.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician successfully placed a stent and a penumbra coil into the target location.While advancing the podj through the microcatheter, the microcatheter dislocated from the aneurysm.It was reported that approximately three to five centimeters of the proximal end of the podj was in the microcatheter and the renal artery.While attempting to retract the podj, the podj unintentionally detached.The detached podj migrated into the upper segment of the renal artery.The physician then attempted to retrieve the detached podj using snare devices through the stent into the arterial lumen and into the upper segment of the renal artery but was unsuccessful.The physician then performed a stent-in-stent implantation to secure the podj to the renal artery wall.The procedure ended at this point.

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.

Event Description

The patient was undergoing a stent-assisted coiling procedure in the left renal artery using a pod packing coil (packing coil), a non-penumbra microcatheter, a non-penumbra sheath, and a stent.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician successfully placed a stent and a penumbra coil into the target location.While advancing the packing coil through the microcatheter, the microcatheter dislocated from the aneurysm.It was reported that approximately three to five centimeters of the proximal end of the packing coil was in the microcatheter and the renal artery.While attempting to retract the packing coil, the packing coil unintentionally detached.The detached packing coil migrated into the upper segment of the renal artery.The physician then attempted to retrieve the detached packing coil using snare devices through the stent into the arterial lumen and into the upper segment of the renal artery but was unsuccessful.The physician then performed a stent-in-stent implantation to secure the packing coil to the renal artery wall.The procedure ended at this point.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report 3005168196-2024-00055.1.Section b.Box 5.Describe event or problem foreign body embolization is included as a possible complication in the instructions for use (ifu) for the penumbra embolization coils.Evaluation of the returned packing coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the coil detachment occurred due to the sr component fracture.If the packing coil is retracted against resistance, the sr component may fracture causing the embolization coil to detach.The detached embolization coil was not returned for evaluation.The patient¿s tortuous anatomy may have contributed to resistance during retraction of the packing coil.Further evaluation revealed kinks on the pusher assembly.This damage was incidental to the reported complaint and likely occurred during packaging for return to penumbra.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: POD PACKING COIL
• Type of Device: 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: 18745504
• MDR Text Key: 335813645
• Report Number: 3005168196-2024-00055
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F88723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention