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

Catalog Number	RBYPODJ60
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
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 numbers: 3005168196-2020-00968, 3005168196-2020-00970, 3005168196-2020-00971.
Event or Problem Description
The patient was undergoing a coil embolization in the aorta using ruby coils, pod packing coils (podjs) and a lantern delivery microcatheter (lantern).During the procedure, the physician placed three ruby coils into the target vessel using the lantern.While attempting to insert the next coil, a ruby coil into the lantern, the pusher assembly of the ruby coil kinked.Subsequently, the ruby coil detached within its introducer sheath; therefore, the ruby coil was removed.The physician then placed two ruby coils into the target vessel using the lantern.While attempting to insert a podj into the lantern, the same issue occurred.The pusher assembly of the podj kinked and subsequently, the podj detached within its introducer sheath; therefore, the podj was removed.The physician then placed one podj into the target vessel using the lantern.While attempting to insert a ruby coil into the lantern, the pusher assembly of the ruby coil kinked.Subsequently, the ruby coil detached within its introducer sheath; therefore, the ruby coil was removed.Then, the physician attempted to insert a podj into the lantern; however, the same issue occurred; therefore, the podj was removed.The procedure was completed using a ruby coil and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10290760
• Report Number: 3005168196-2020-00969
• Device Sequence Number: 812432
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 06/24/2020
• 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 Catalogue Number: RBYPODJ60
• Device Lot Number: F97552
• 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: 06/24/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Date Report Sent to FDA: 01/01/2005