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

Catalog Number	RBYPODJ45
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 1.3005168196-2017-02257, 2.3005168196-2017-02259, 3.3005168196-2017-02260.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (podjs), pod8s and pod6s.It was noted that the patient anatomy was tortuous.During the procedure, while attempting to advance a podj through a non-penumbra microcatheter, the physician experienced resistance and decided to remove the podj; however, upon retraction, the podj unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached coil was removed and the coil was flushed out.After that, the microcatheter was reinserted into the patient¿s body; however, it was reported that the same issue occurred with another podj, a pod8 and a pod6.The procedure was completed using additional podj 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 was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2017-02258.Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 3005168196-2017-02258.This report is associated with mfr report numbers: 3005168196-2017-02257, 3005168196-2017-02259, 3005168196-2017-02260.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7131196
• Report Number: 3005168196-2017-02258
• Device Sequence Number: 2144531
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 11/24/2017
• 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: Physician
• Device Expiration Date: 08/14/2025
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F78713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 06/22/2020
• 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