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

Catalog Number	RBYPODJ60
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
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 procedure to treat an arteriovenous fistula (avf) using pod packing coils (podj) and two px slim delivery microcatheters (px slims).During the procedure, the physician advanced two px slims to the target vessel from two different access points.While advancing the podj through one of the px slims, the physician experienced resistance approximately ten centimeters into the px slim; therefore, the podj was removed.The physician then attempted to advanced the podj into the other px slim; however, the same issue occurred.Therefore, the podj was removed.The procedure was completed using additional podjs and both px slims.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 stretch resistance wire (sr wire) was fractured.The proximal constraint sphere and the pull wire were within the distal detachment tip.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned podj revealed that the sr wire was fractured, and the embolization coil was detached.If the device is forcefully retracted against resistance, damage such as these may occur.The px slim identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance was unable to be determined.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: 9566764
• Report Number: 3005168196-2020-00036
• Device Sequence Number: 11311890
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• 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): 12/19/2019
• 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 Catalogue Number: RBYPODJ60
• Device Lot Number: F91607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 03/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005