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

Model Number	RBYPOD8
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
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 number: 3005168196-2020-00709.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using pod coils and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, the physician advanced a pod coil into the target vessel using the microcatheter; however, the physician was not satisfied with the placement of the pod coil and wanted to place it more distal to the aneurysm.While retracting the pod coil to reposition the microcatheter, resistance was encountered and subsequently, the pod coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed and the pod coil was flushed out.While advancing a new pod coil through the microcatheter, the pod coil unintentionally detached inside the microcatheter prior to exiting the microcatheter; therefore, the microcatheter containing the detached pod coil was removed.The procedure was completed using a new pod coil and a new microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10117072
• Report Number: 3005168196-2020-00708
• Device Sequence Number: 1847915
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 05/14/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2024
• Device Model Number: RBYPOD8
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F72972
• 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: 05/14/2020
• Initial Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 73
• Date Report Sent to FDA: 01/01/2005