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

Catalog Number	RBYPODJ45
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization in the common iliac artery using pod packing coils (podjs).During the procedure, the physician successfully placed five ruby coils in the target vessel using a lantern delivery microcatheter (lantern).While advancing a podj into the target vessel, the physician noticed that part of the podj came out of the aneurysm; therefore, the physician decided to remove the podj.While retracting the podj, no resistance was experienced; however, the podj unintentionally detached in the lantern with part of the podj inside of the introducer sheath; therefore, the physician successfully removed the introducer sheath with the podj inside.The procedure was completed using a new podj and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pull wire was advanced distal to the distal detachment tip (ddt) and was not within the alignment feature.The embolization coil was detached from the pusher assembly and had offset coil winds.The embolization coil was stuck inside the non-penumbra guide catheter.The non-penumbra catheter was undamaged.Conclusions: evaluation of the returned podj revealed that the pull wire was out of its initial position within the pusher assembly ddt alignment feature and extended distally to the ddt.If the device is forcefully retracted against resistance, the polymer section of the pusher assembly may likely elongate past the reach of the pull wire.If this occurs, the proximal constraint sphere may release from the ddt and allow the embolization coil to detach.The lantern identified in the complaint was not returned for evaluation.The root cause of the complaint could not be determined.Further investigation revealed offset coil winds along the length of the embolization coil.These damages were likely incidental to the complaint.Penumbra coils 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.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8965758
• Report Number: 3005168196-2019-01696
• Device Sequence Number: 16774505
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/07/2019
• 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: 01/24/2026
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F81644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005