MAUDE Adverse Event Report: PENUMBRA, INC. POD6; HCG, KRD

Catalog Number	RBYPOD6
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
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 splenic artery using pod6s.During the procedure, the physician attempted to place a pod8 as the first coil in the outflow vessel with a non-penumbra microcatheter; however, the pod8 did not take its intended shape.It was reported that the pod8 was oversized and therefore, it was removed.The physician then attempted to place a pod6 into the outflow vessel using the same microcatheter; however, the base catheter being used could not be stabilized; therefore, the pod6 was retracted and flushed.When the pod6 was advanced again, the physician experienced resistance and the pod6 would not advance past the introducer sheath.Therefore, the pod6 was removed.The procedure was completed using additional pod6s, ruby coils, non-penumbra embolic agents, and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: POD6
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8111654
• Report Number: 3005168196-2018-02323
• Device Sequence Number: 13876592
• 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): 10/29/2018
• 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: 08/29/2025
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F79022
• 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: 10/29/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005