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

Catalog Number RBYPODJ45

Device Problems Physical Resistance/Sticking (4012); Premature Separation (4045)

Patient Problem Vasoconstriction (2126)

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-01610.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery to treat a gastrointestinal bleeding (gi bleed) using a pod packing coil (podj) and a lantern delivery microcatheter (lantern).During the procedure, the physician experienced resistance after partially advancing a podj into the target vessel using a lantern and decided to retract the podj and redeploy it to get a better packing density.After taking the slack out of the microcatheter, the physician gently pulled back on the podj pusher assembly; however, the podj unintentionally detached.Therefore, the physician used a syringe to aspirate on the lantern while the lantern was gently pulled out of the guide catheter with the podj mostly inside the lantern.After removing the lantern and the detached coil, the vessel spasmed.The physician was unable to gain back access because of the spasm and ended the procedure.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, 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.

Manufacturer Narrative

This report is associated with mfr report number: 3005168196-2018-01610.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7791851
• MDR Text Key: 117420608
• Report Number: 3005168196-2018-01611
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 00814548017662
• 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,Followup
• Report Date: 01/01/2005,07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F81762
• 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
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR