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

Catalog Number RBYPODJ45

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2017

Event Type  malfunction  

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: 3005168196-2017-02258, 3005168196-2017-02259, 3005168196-2017-02260.The hospital disposed of the device.

Event 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.

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: 3005168196-2017-02257.This report is associated with mfr report numbers: 3005168196-2017-02258, 3005168196-2017-02259, 3005168196-2017-02260.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7131146
• MDR Text Key: 95911362
• Report Number: 3005168196-2017-02257
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (y/n): Y
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F78713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1