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

Catalog Number	RBYPOD4
Medical Device Problem Code	Failure to Fold (1255)
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.This report is associated with mfr report numbers: 3005168196-2018-01897; 3005168196-2018-01898.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using pod4s and pod packing coils (podjs).During the procedure, a pod4 was not forming properly in the target location and, therefore, the pod4 was removed.The physician then successfully deployed and detached a ruby coil in the target location using the same lantern delivery microcatheter (lantern).Next, the physician attempted to place a podj; however, while advancing the podj into the target location, the lantern kicked out of place.The podj was therefore removed and the physician adjusted the lantern and attempted to place another podj.However, the podj was the wrong size.While retracting to remove the podj, it unintentionally detached.The physician attempted to remove the detached podj using a snare device; however, the podj broke.The physician was able to remove part of the embolization coil, and the other part was left in the patient¿s hepatic artery.The procedure ended at this point.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: 7906738
• Report Number: 3005168196-2018-01896
• Device Sequence Number: 1539844
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/29/2018
• 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: 06/19/2025
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F77814
• 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: 08/29/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 98
• Date Report Sent to FDA: 01/01/2005