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

Catalog Number RBYPODJ45

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2018

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

The patient was undergoing a coil embolization procedure using pod packing coils (podjs).During the procedure, the physician successfully placed multiple ruby coils using a non-penumbra microcatheter.The physician then attempted to place a podj, however, the podj became stuck within the microcatheter while being advanced into the patient.Therefore, the podj was removed, and the procedure was completed using new coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The pull wire and pet bump were protruding out from the distal detachment tip (ddt).The embolization coil was intact with the pusher assembly.The embolization coil had offset coil winds on the proximal portion of the coil.The returned device was unable to advance through its introducer sheath.Conclusion: evaluation of the returned podj revealed offset coil winds.If the podj introducer sheath is not aligned properly with the hub of the parent device, resistance may be experienced.If the podj is forcefully advanced against resistance, damage such as offset coil winds may occur.Further evaluation revealed a pusher assembly kink and the pull wire protruding distally from the ddt.If the device is forcefully advanced against resistance, the pull wire pet bump may push through the alignment feature causing it to protrude distally from the ddt.Based on the reported complaint, the kink was likely incidental and may have occurred during packaging for return to penumbra.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: 7886927
• MDR Text Key: 120698133
• Report Number: 3005168196-2018-01855
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• 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: 01/01/2005,07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F78713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• 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: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1