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

Catalog Number	RBYPODJ60
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 in the pancreaticoduodenal artery using pod packing coils (podjs) and a non-penumbra microcatheter.During the procedure, the physician successfully implanted two podjs in the target vessel using the microcatheter.While filling up aneurysm sac with another podj, the physician experienced resistance and decided to remove the podj.While re-sheathing the podj, the physician realized that the podj had unintentionally detached inside the microcatheter; therefore, the physician pulled the podj from the microcatheter and removed the sheath along with the detached podj.The procedure was completed using another podj and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2020-00107.1.Section h.Box 3.Device returned to manufacturer? results: offset coil winds were present throughout the length of the embolization coil.The stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was not present.Conclusions: evaluation of the returned pod pc embolization coil revealed a fracture sr wire.If the device is forcefully retracted against resistance, damage such as this may occur.If the sr wire fractures from the proximal constraint sphere, the embolization coil will detach from the pusher assembly.The pod pc pusher assembly and the microcatheter used in the procedure were not returned for evaluation; therefore, the root cause of resistance experienced during the procedure 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.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9638015
• Report Number: 3005168196-2020-00107
• Device Sequence Number: 2678474
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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): 01/06/2020
• 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: F92212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005