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

Catalog Number	PODH1
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
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 in the internal iliac artery using a pod detachment handle (handle).During the procedure, the physician removed the handle from its packaging and found that the proximal end of the handle was broken; however, the physician tried to re-assemble it and use it.While attempting to detach a pod8 using the handle, the pod8 pusher assembly came through the back of the handle.Therefore, the handle was removed and the procedure was completed using another handle to detach the same pod8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pod detachment handle (handle) was undamaged.Conclusions: evaluation of the returned handle revealed a fully functional device.The returned device was undamaged.The device was tested using a handle fixture and performed within specification.The handle was opened to further evaluate the device and no issue was found.The complaint could not be confirmed.The root cause of the reported complaint could not be determined.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: POD DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8249475
• Report Number: 3005168196-2019-00096
• Device Sequence Number: 14000689
• Product Code: HCG
• UDI-Device Identifier: 00814548013954
• UDI-Public: 00814548013954
• 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): 12/17/2018
• 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: 03/13/2021
• Device Catalogue Number: PODH1
• Device Lot Number: F82324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 70
• Date Report Sent to FDA: 01/01/2005