MAUDE Adverse Event Report: PENUMBRA, INC. POD DETACHMENT HANDLE; HCG, KRD

Catalog Number	PODH1
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the handle had an unknown material inside the nosecone.The nosecone to the handle was blocked by an unknown material.The unknown material was removed and the handle was functionally tested within specification.A clicking sound was observed during the functional test.Conclusions: evaluation of the returned handle revealed that the nosecone was blocked by an unknown material.The root cause of the unknown material inside the nosecone of the handle could not be determined.The unknown material was removed and the handle was functionally tested within specification.A click sound was observed during the functional test.Penumbra handles are visually inspected and 100% functionally tested during incoming inspection by quality.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 number: 3005168196-2018-02173.
Event or Problem Description
The patient was undergoing a coil embolization procedure on the splenic artery using a pod5 and pod detachment handle (handle).During the procedure, the physician was unable to detach the pod5 using the handle.It was also reported that the handle would not click.Therefore, the handle was removed, and a new handle was used to complete the procedure.There was no report of an adverse effect to the patient.

• Brand Name: POD DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8035681
• Report Number: 3005168196-2018-02172
• Device Sequence Number: 13827574
• Product Code: HCG
• UDI-Device Identifier: 00814548013954
• UDI-Public: 00814548013954
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 10/03/2018
• 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: 02/21/2021
• Device Catalogue Number: PODH1
• Device Lot Number: F81976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 82
• Date Report Sent to FDA: 01/01/2005