MAUDE Adverse Event Report: PENUMBRA, INC. POD8; HCG, KRD

Catalog Number	RBYPOD8
Medical Device Problem Codes	Failure to Fold (1255); Inadequacy of Device Shape and/or Size (1583); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
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: 3005168196-2018-02191; 3005168196-2018-02192; 3005168196-2018-02193; 3005168196-2018-02194.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils, pod8s, pod packing coils (podjs), and lantern delivery microcatheters (lanterns).During the procedure, the physician attempted to place a pod8, however, it was not taking its intended shape.The physician removed the pod8 and advanced the lantern more distal, however the physician then was unable to advance the pod8 out of its introducer sheath.The physician therefore removed the pod8 and was able to successfully place a new pod8 in the target vessel.It was noticed that the lantern became kinked after deploying the pod8 and therefore, the lantern was removed and replaced with a new lantern.The physician had difficulty advancing the new lantern into the non-penumbra catheter; therefore, it was removed and another lantern was opened.Afterwards, a podj was selected, however, the physician was unable to advance it out of its introducer sheath.A kink was found in the introducer sheath and, therefore, the podj was removed.Another podj was selected and successfully implanted.The physician then attempted to place a new ruby coil; however, while attempting to load it into the microcatheter, the assisting surgeon accidentally kinked the pusher assembly.The ruby coil was therefore removed.The procedure was then completed using additional ruby coils, a pod8 and a podj with the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8030315
• Report Number: 3005168196-2018-02190
• Device Sequence Number: 11045625
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018
• 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: 07/10/2025
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F78116
• 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: 10/05/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59
• Date Report Sent to FDA: 01/01/2005