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	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous fistula using pod packing coils (podjs).During the procedure, while advancing the last podj through a lantern delivery microcatheter (lantern), the podj unintentionally detached inside the lantern.Therefore, the physician flushed the detached podj into the target vessel and the procedure was ended at that point.There was no noted damage to the lantern and 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 pusher assembly had slight bends along its length.The embolization coil was detached and the proximal constraint sphere was inside the distal detachment tip (ddt) indicating a fractured sr wire.The embolization coil was detached; therefore, the returned device was unable to be functionally tested.The pusher assembly was kinked by the investigator when archiving the device.Conclusions: evaluation of the returned podj revealed embolization coil was detached due to a stretch resistant wire fracture (sr wire).If the embolization coil is forcefully manipulated within patient anatomy the sr wire may fracture causing the embolization coil to detach.The pet lock was intact and the pusher assembly was largely undamaged.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7894137
• Report Number: 3005168196-2018-01850
• Device Sequence Number: 13789678
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018
• 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: 03/24/2026
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F82529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Date Report Sent to FDA: 01/01/2005