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

Catalog Number	RBYPODJ15
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The pusher assembly was kinked approximately 48.5, 49.5, 50.0 and 58.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and was within the distal tip of the lantern.The stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was within the pusher assembly distal detachment tip (ddt).Conclusions: evaluation of the returned podj revealed a fractured sr wire.If the podj is forcefully retracted against resistance, damage such as this may occur.If the sr wire fractures, the embolization coil will likely become detached from its pusher assembly.Further evaluation revealed pusher assembly kinks and a fracture.These damages were likely incidental to the reported complaint.Evaluation of the returned lantern revealed an ovalization on the distal tip and the podj embolization coil was stuck within the lantern.If the device is gripped or pinched during use, damage such as an ovalization may occur.This damage may have contributed to the resistance experienced during the procedure.Penumbra coils and catheters 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.This report is associated with mfr report number: 3005168196-2019-02163.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal maxillary artery using pod packing coils (podjs) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a podj into the target vessel and proceeded to retract the podj in order to reposition it.However, while retracting the podj, the physician encountered minimal resistance and the podj unintentionally detached with part of the podj within the lantern and the other part within the patient's vessel.Therefore, the lantern and detached podj were removed together.The procedure was completed using another microcatheter and coils.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: 9355069
• Report Number: 3005168196-2019-02162
• Device Sequence Number: 1954097
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2019
• 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: 09/18/2024
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: C11915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• 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: 10/25/2019
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005