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

Catalog Number	PODH1
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Contamination /Decontamination Problem (2895); Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/30/2018
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 number: 3005168196-2018-00857.The hospital disposed of the device.
Event or Problem Description
During preparation for a coil embolization procedure, the pod packing coil (podj) was accidentally dropped on the floor and the pod detachment handle (handle) was manually contaminated upon removal from the packaging.The reported issues occurred prior to use and therefore, the podj and the handle were not used in the procedure.The procedure was completed using new podj, ruby coil and ruby coil detachment handle (handle).

• Brand Name: POD DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7461702
• Report Number: 3005168196-2018-00856
• Device Sequence Number: 11020562
• Product Code: HCG
• UDI-Device Identifier: 00814548013954
• UDI-Public: 00814548013954
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• 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): 03/30/2018

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: Radiologic Technologist
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: PODH1
• Device Lot Number: F65953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1