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

Catalog Number RBYPODJ30

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  Injury  

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 numbers: 3005168196-2018-01896; 3005168196-2018-01897.

Event Description

The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using pod4s and pod packing coils (podjs).During the procedure, a pod4 was not forming properly in the target location and, therefore, the pod4 was removed.The physician then successfully deployed and detached a ruby coil in the target location using the same lantern delivery microcatheter (lantern).Next, the physician attempted to place a podj; however, while advancing the podj into the target location, the lantern kicked out of place.The podj was therefore removed and the physician adjusted the lantern and attempted to place another podj.However, the podj was the wrong size.While retracting to remove the podj, it unintentionally detached.The physician attempted to remove the detached podj using a snare device; however, the podj broke.The physician was able to remove part of the embolization coil, and the other part was left in the patient¿s hepatic artery.The procedure ended at this point.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: 7906747
• MDR Text Key: 121638788
• Report Number: 3005168196-2018-01898
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/29/2018

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: F81927
• 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: 08/29/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 98