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

Catalog Number RBYPODJ45-A

Device Problems Device Damaged Prior to Use (2284); Deformation Due to Compressive Stress (2889); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

While patient was undergoing a coil embolization procedure using pod packing coil (podj), the technician accidentally kinked the pusher wire of a podj while removing it from the packaging hoop.The damage to the podj was found prior to use, therefore, the podj was not used in the procedure.The procedure was completed using a new podj and a non-penumbra microcatheter.

Manufacturer Narrative

Results: the podj was fractured approximately 5.0 cm from the proximal end of the pusher assembly.The pusher assembly had bends along its length.Conclusion: evaluation of the returned podj revealed that the pusher assembly was fractured on its proximal end.This damage is likely a result of being forcefully mishandled during removal from the packaging hoop.Penumbra coils are 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
• MDR Report Key: 7954428
• MDR Text Key: 123416421
• Report Number: 3005168196-2018-01992
• 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
• 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: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ45-A
• Device Lot Number: F82148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• 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: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1