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

Model Number	RBYPOD6
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
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 a branch off of a fistula using pod coils, a non-penumbra microcatheter, a non-penumbra catheter, and a non-penumbra sheath.During the procedure, the physician was unable to get the pod8 to anchor properly in the target vessel.The pod8 was retracted and re-advanced but the same issue occurred.Next, the physician attempted to use a pod6 but this coil became stuck in the middle of the microcatheter.Therefore, the pod6 was removed and the microcatheter was flushed.The physician made another attempt with the same pod6 without success.Therefore, the pod6 was not used in the procedure.The procedure was completed using another pod6, the same microcatheter, the same catheter, and the same sheath.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: 11364676
• Report Number: 3005168196-2021-00330
• Device Sequence Number: 883541
• Product Code: HCG
• UDI-Device Identifier: 00814548013817
• UDI-Public: 00814548013817
• 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): 01/27/2021
• 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: 08/22/2025
• Device Model Number: RBYPOD6
• Device Catalogue Number: RBYPOD6
• Device Lot Number: C04366
• 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: 01/27/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 71
• Date Report Sent to FDA: 01/01/2005