MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Catalog Number	RBYPOD5
Medical Device Problem Codes	Failure to Fold (1255); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
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.This report is associated with mfr report numbers: 3005168196-2018-00592, 3005168196-2018-00593, 3005168196-2018-00594, 3005168196-2018-00595.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod4, a pod5, a pod6 and pod8's.During the procedure, while attempting to advance a pod4 in the target vessel using a lantern delivery microcatheter (lantern), the pod4 would not take its intended shape and the coil was removed.A pod5, pod6 and two pod8's were opened; however, the physician experienced the same issue.Therefore, the physician removed the pods and successfully completed the procedure using ruby coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, 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 numbers: 3005168196-2018-00592, 3005168196-2018-00593, 3005168196-2018-00594, 3005168196-2018-00595.

• Brand Name: POD5
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7371140
• Report Number: 3005168196-2018-00597
• Device Sequence Number: 555178
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: 09/11/2025
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F79490
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR