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

Model Number	RBYPCLP03
Medical Device Problem Codes	Material Deformation (2976); 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	07/20/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using packing coil lp.During the procedure, while attempting to advance a packing coil lp, the physician experienced resistance and decided to retract the packing coil lp to readjust it.However, while retracting the coil, the physician experienced resistance again and; consequently, the pusher assembly of the packing coil lp became kinked.Therefore, the packing coil lp was removed.The procedure was completed using another packing coil lp.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.
Additional Manufacturer Narrative
Please note that the device in complaint was not expected to be returned; however, on 11/3/2022 the device was received.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda) and returned to manufacturer on (mm/dd/yyyy) 2.Section h.Box 3: device returned to manufacturer? 3.Section h.Box 3: device evaluated by manufacturer? 4.Section h.Box 6: method code 1 5.Section h.Box 6: results code 1, results code 2, results code 3, and results code 4 6.Section h.Box 6: conclusions code 1 additional information was added to: 1.Section d.Box 10: returned to manufacturer on (mm/dd/yyyy) evaluation of the returned packing coil lp confirmed the pusher assembly was kinked.If the device is manipulated against resistance during use, damage such as a kink may occur.Further evaluation revealed that the pusher assembly had additional kinks and a fracture, and the embolization coil was detached from the pusher assembly inside the introducer sheath.This damage was incidental to the reported complaint and may have occurred during packaging for return to penumbra.Due to the return damage, the device could not be functionally tested.The root cause of resistance during the procedure could not be determined.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.H3 other text : placeholder.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 10758722
• Report Number: 3005168196-2020-01842
• Device Sequence Number: 3261724
• Product Code: HCG
• UDI-Device Identifier: 00815948021891
• UDI-Public: 00815948021891
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2022
• 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: 02/24/2025
• Device Model Number: RBYPCLP03
• Device Catalogue Number: RBYPCLP03
• Device Lot Number: F96506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 11/11/2022
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/25/2021; 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005