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

Catalog Number	RBYPODJ30
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly was kinked approximately 4.5 cm, 6.0 cm, 14.0 cm, 72.0 cm, 73.5 cm, 75.5 cm, 90.0 cm and 120.0 cm from the proximal end.The distal end of the pusher assembly was outside of the distal end of the introducer sheath.The proximal constraint sphere was inside the distal detachment tip (ddt) and the stretch resistant wire (sr wire) was fractured.Conclusions: evaluation of the returned podj revealed the embolization coil had detached due to an sr wire fracture.It was reported that the podj became stuck within the non-penumbra microcatheter.If the device is forcefully retracted against resistance, the sr wire may fracture causing the coil to detach.Further evaluation revealed kinks along the pusher assembly.Based on the return condition and reported complaint, some of these kinks may be incidental to the reported complaint and may have occurred during packaging for return to penumbra.The sr wire fracture and pusher kinks were not identified in the complaint; therefore, this damage was likely incidental to the reported issue.The embolization coil and non-penumbra catheter were not returned for evaluation; therefore, the root cause of the reported resistance could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a pod packing coil (podj).During the procedure, the podj became stuck within the non-penumbra microcatheter.The physician was able to remove the podj from the microcatheter.There was no report of an adverse effect to the patient.No further details were provided.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a pod packing coil (podj).During the procedure, the podj became stuck at the distal end of a non-penumbra microcatheter.The physician was able to remove the podj from the microcatheter.The procedure was then completed using new coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 01/18/2019.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8262444
• Report Number: 3005168196-2019-00120
• Device Sequence Number: 18871745
• Product Code: HCG
• UDI-Device Identifier: 00814548016719
• UDI-Public: 00814548016719
• Combination Product (Y/N): Y
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018
• 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: 07/13/2024
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F70629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 01/31/2019
• 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