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

Catalog Number	PODH1
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2017
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2017-00951.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod detachment handle (podh1) and pod8 coils (pod8¿s).During the procedure, the physician deployed a pod8 into the target vessel and then used the podh1 to detach the coil.It was observed that the black marker on the pusher assembly separated.However, when the pusher assembly was removed from the patient, the pod8 was still attached.The procedure was then completed using additional coils and the same podh1.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: 6654877
• Report Number: 3005168196-2017-00952
• Device Sequence Number: 13822613
• Product Code: HCG
• UDI-Device Identifier: 00814548013954
• UDI-Public: 00814548013954
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2017

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 Catalogue Number: PODH1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2017
• Initial Report FDA Received Date: 06/20/2017
• 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