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

Model Number	RBYPCLP15
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using a packing coil lp.During the procedure, the packing coil lp 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
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then the packing coil lp was able to advance through its introducer sheath without an issue.Further evaluation of the device revealed kinks throughout the length of the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12752585
• Report Number: 3005168196-2021-02492
• Device Sequence Number: 16520847
• Product Code: HCG
• UDI-Device Identifier: 00815948021921
• UDI-Public: 00815948021921
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021
• 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: RBYPCLP15
• Device Catalogue Number: RBYPCLP15
• Device Lot Number: F103535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• 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: 10/12/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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 Age: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005