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

Catalog Number	RBYPODJ15
Medical Device Problem Codes	Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned podj revealed that the pet lock was broken and the embolization coil was detached from its pusher assembly.If the pusher assembly is forcefully retracted by the proximal end where the pet lock is located, damage such as a broken pet lock may occur.If the pet lock is broken and the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.The embolization coil and the lantern identified in the complaint were not returned for evaluation.Therefore, the root cause of the reported complaint could not be determined.Further evaluation of the podj revealed that the pusher assembly was kinked.This kink was likely incidental and may have occurred while packaging the device for return to penumbra.Penumbra coils and catheters are visually 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat gastric varices using a pod packing coil (podj).During the procedure, while attempting to advance a podj through a lantern delivery microcatheter (lantern), the initial pushes were very smooth, but thereafter, the podj just completely stopped; therefore, the lantern and podj were removed.It was reported that the podj introducer sheath might have not been off completely and that the physician was accidentally pushing the introducer sheath with the pusher assembly.The procedure was completed using other coils.There was no noted damage to the lantern after removal.Additionally, there was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7822917
• Report Number: 3005168196-2018-01686
• Device Sequence Number: 1313562
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2026
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F83753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005