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

Catalog Number	PODH1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the nose cone was detached from the handle and one of the tabs was broken.Conclusions: evaluation of the returned handle revealed the nose cone was disconnected from the handle.One of the tabs was damaged and unable to hold the nose cone in place.This damage may have occurred as a result of mishandling during transit to the customer.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.
Event or Problem Description
During a coil embolization procedure, the physician noted that the distal part of the pod detachment handle (handle) was missing upon removal from the packaging.It was found later that the distal part of the handle was disconnected from the handle and was inside the packaging.The reported issue was found prior to use.Therefore, the handle was not used in the procedure.The procedure was completed using a new handle.
Additional Manufacturer Narrative
Report source: distributor, foreign.

• Brand Name: POD DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7615667
• Report Number: 3005168196-2018-01227
• Device Sequence Number: 16489577
• Product Code: HCG
• UDI-Device Identifier: 00814548013954
• UDI-Public: 00814548013954
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: Physician
• Device Expiration Date: 06/06/2020
• Device Catalogue Number: PODH1
• Device Lot Number: F77523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1