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	11/21/2018
Type of Reportable Event	Serious Injury
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 procedure to treat a cavernous carotid fistula (ccf) in the internal carotid artery (ica) using pod packing coils (podjs).During the procedure, after advancing approximately half of a podj into the sac of the fistula using a lantern delivery microcatheter (lantern), the physician was not satisfied with the position of the podj and decided to withdraw it.However, while repositioning, the podj unintentionally detached.The physician then made a few attempts to push the remaining podj into the target vessel, but was unsuccessful.Therefore, the physician removed the lantern and successfully snared the podj out of the patient's body.The procedure was completed using other coils, an additional 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.Bends were present along the pusher assembly length.The sr wire was fractured and embolization coil was unraveled.Proximal constraint sphere was inside the distal detachment tip.Conclusions: evaluation of the returned podj revealed that the sr wire was fractured and the embolization coil was unraveled.If the device is forcefully retracted against resistance, the sr wire may break which will likely result in the coil winds unraveling.Some unraveling observed during the evaluation is likely a result of the device being handled when packaged for return.Further evaluation revealed that the pusher assembly was bent in multiple locations; these bends were likely incidental and may have occurred during packaging for return.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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8188180
• Report Number: 3005168196-2018-02484
• Device Sequence Number: 11290811
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• 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,Followup
• Report Date (Section B): 11/21/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2024
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F72020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005