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

Catalog Number RBYPODJ60

Device Problems Detachment Of Device Component (1104); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

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.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (podj).It was reported that the patient¿s anatomy was tortuous.During the procedure, while placing a podj in the target vessel using a lantern delivery microcatheter (lantern), the physician determined that the podj was too long and decided to withdraw it.However, upon retraction, the podj unintentionally detached in the lantern; therefore, it was removed.The procedure was successfully completed using ruby coils and the same lantern.The physician mentioned that tortuosity may have been a factor.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (podj).It was reported that the patient¿s anatomy was tortuous.During the procedure, while placing a podj in the target vessel using a lantern delivery microcatheter (lantern), the physician determined that the podj was too long and decided to withdraw it.However, upon retraction, the podj unintentionally detached in the lantern and was pulled out of the hub of the lantern.The procedure was successfully completed using ruby coils and the same lantern.The physician mentioned that tortuosity may have been a factor.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
• MDR Report Key: 7664984
• MDR Text Key: 113302129
• Report Number: 3005168196-2018-01341
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (y/n): Y
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/11/2018

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
• Device Operator: Physician
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F82530
• Was Device Available for Evaluation?: No
• 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: 06/11/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1