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

Model Number	RBYPCLP10
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If the pusher assembly mid-joint is retracted through the introducer sheath, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink observed near the pusher assembly mid-joint.During functional testing, the pusher assembly mid-joint was able to be advanced from its returned position without an issue; however, the pusher assembly was unable to be advanced through its introducer sheath due to the kink in the pusher assembly, and no further functional testing could be performed.Penumbra products are visually inspection during in-process 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a gastrointestinal (gi) bleed using a packing coil lp, a non-penumbra microcatheter, and a guidewire.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 another lp coil.There was no report of an adverse effect to the patient.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12716785
• Report Number: 3005168196-2021-02432
• Device Sequence Number: 11873336
• Product Code: HCG
• UDI-Device Identifier: 00815948021914
• UDI-Public: 00815948021914
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/28/2021
• 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: 09/23/2025
• Device Model Number: RBYPCLP10
• Device Catalogue Number: RBYPCLP10
• Device Lot Number: F100542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• 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: 10/04/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 79
• Date Report Sent to FDA: 01/01/2005