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

Model Number	RBYPCLP60
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2021
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 in the splenic artery branch using packing coil lps.During the procedure, a packing coil lp became stuck and would not advance at all past its initial position within its introducer sheath.Therefore, the packing coil lp was removed.The procedure was completed using a new packing coil lp.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report: 1.Section h.Box 6.Results code 1 should have been blank.2.Section h.Box 6.Conclusions code 1 should have been blank.Evaluation of the returned packing coil lp could not confirm that the device could not be advanced from its initial position at all.Further evaluation revealed that the embolization coil had offset coil winds, the embolization was returned advanced outside the distal tip of the introducer sheath, and the friction lock from the additional introducer sheath was on the embolization coil.This damage is incidental to the reported complaint.Based on the returned condition, the root cause of the reported complaint could not be determined.During the functional test, resistance was encountered while attempting to advance packing coil lp from its returned position due to the offset coil winds on the embolization coil, and the device could not be advanced any further.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12271636
• Report Number: 3005168196-2021-01738
• Device Sequence Number: 17237336
• Product Code: HCG
• UDI-Device Identifier: 00815948021952
• UDI-Public: 00815948021952
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021
• 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: 01/26/2026
• Device Model Number: RBYPCLP60
• Device Catalogue Number: RBYPCLP60
• Device Lot Number: F103537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005