MAUDE Adverse Event Report: PENUMBRA, INC. POD4; HCG, KRD

Catalog Number	RBYPOD4
Medical Device Problem Codes	Failure to Fold (1255); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2018
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a pod4.It was noted that the patient¿s anatomy was mildly tortuous and calcified.During the procedure, the physician placed three penumbra coils 400 (pc400s) in the superior gluteal artery using a lantern delivery microcatheter (lantern).Next, the physician placed the lantern in the inferior gluteal artery and attempted to deploy a pod4; however, the pod4 would not take its intended shape.After several failed attempts, the physician decided to withdraw the pod4; however, upon removal, the physician noticed that the pod4 was not attached to its pusher assembly.Therefore, the physician removed the lantern and noticed that the pod4 had unintentionally detached inside the lantern.The physician then removed the detached coil and completed the procedure using the same lantern and eight pc400s.There was no report of an adverse effect to the patient.

• Brand Name: POD4
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7923581
• Report Number: 3005168196-2018-01937
• Device Sequence Number: 19279238
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2018
• 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: 02/24/2026
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F82079
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005