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

Catalog Number RBYPODJ15

Device Problems Failure to Advance (2524); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  malfunction  

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: 3005168196-2018-01995.

Event Description

The patient was undergoing a coil embolization procedure to treat a pseudoaneurysm in the hepatic artery using pod packing coils (podjs).During the procedure, after advancing approximately 25 centimeters of a podj into a non-penumbra microcatheter, the physician experienced resistance and stated that the podj would not go any further; therefore, it was removed and re-sheathed.The physician then flushed the microcatheter and reattempted to advance the podj; however, the same issue occurred.Therefore, it was removed.Next, the physician placed new podj in the target vessel with no issues.While attempting to advance another podj out of its introducer sheath into the microcatheter, the physician experienced resistance and the podj appeared to be stuck in its introducer sheath.Therefore, the physician stopped, pulled the podj back and attempted to advance it again; however, the same issue occurred.Therefore, it was removed.The procedure was completed using other coils.There was no report of an adverse effect to the patient.

• 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: 7949591
• MDR Text Key: 123417789
• Report Number: 3005168196-2018-01996
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 00814548017648
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F81760
• Was Device Available for Evaluation?: No
• 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
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2018
• 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 Age: 68 YR