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

Catalog Number	RBYPODJ30
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-01262.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left subclavian artery using a lantern delivery microcatheter (lantern), pod packing coils (pod pcs), ruby coils, and a catheter.During the procedure, the physician implanted a ruby coil in the target vessel using the lantern.The physician then attempted to implant a pod pc, but the pod pc did not fit in the vessel.Subsequently, the physician decided to remove the pod pc.While retracting the pod pc and the lantern through catheter, the lantern broke at the mid-shaft.It was reported that while removing the pod pc through the lantern, the physician experienced resistance.Therefore, the pod pc and lantern were removed together.The procedure was completed using a non-penumbra catheter, non-penumbra coil, and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, 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: 3005168196-2020-01262.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10440510
• Report Number: 3005168196-2020-01263
• Device Sequence Number: 3975252
• Product Code: HCG
• UDI-Device Identifier: 00814548016719
• UDI-Public: 00814548016719
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020
• 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: RBYPODJ30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/22/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005