MAUDE Adverse Event Report: PENUMBRA, INC. POD 6; HCG, KRD

Catalog Number	RBYPOD6
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
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: 3005168196-2019-00867.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod6s and pod8s.It should be noted that the target artery was difficult to access.During the procedure, the physician advanced a pod8 into a lantern delivery microcatheter (lantern).While attempting to implant the pod8, it was reported that the pod8 would not anchor or take its intended shape and began to flow down the artery.The pod8 was then re-sheathed and removed from the procedure.The physician continued the procedure and successfully implanted a pod6.However, while attempting to implant the next coil, a pod packing coil (pod pc), it was reported that the pod pc made contact with the pod6 coil pack.As a result, the pod6 migrated out of the target vessel to an undesired location.The pod pc was subsequently removed and the physician used a snare to retrieve the pod6 from the patient.The procedure was completed using ruby coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD 6
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8577826
• Report Number: 3005168196-2019-00868
• Device Sequence Number: 1537491
• Product Code: HCG
• UDI-Device Identifier: 00814548013817
• UDI-Public: 00814548013817
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F88053
• 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: 04/05/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005