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

Catalog Number	RBYPCLP30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the endoleak sack using packing coil lps, a lp system detachment handle (lp handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a packing coil lp through the microcatheter and into the target vessel, then attempted to detach it using the lp handle; however, the packing coil lp failed to detach.Next, the physician attempted to manually detach the packing coil lp, but the coil would still not detach.The physician then decided to remove the packing coil lp.However, while retracting the packing coil lp, it unintentionally detached in the microcatheter.Therefore, the physician flushed the detached coil into the target vessel.Next, the physician advanced a new packing coil lp into the target vessel and attempted to detach it using the lp handle; however, the coil failed to detach.The physician then attempted to manually detach the packing coil lp, but the coil would still not detach.Therefore, the packing coil lp was removed.It was reported that the same issue occurred with another packing coil lp; therefore, the packing coil lp was also removed.The procedure was completed using additional packing coil lps, the same lp handle and microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.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.

• 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: 14489980
• Report Number: 3005168196-2022-00230
• Device Sequence Number: 5336381
• Product Code: HCG
• UDI-Device Identifier: 00815948021938
• UDI-Public: 815948021938
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2022
• 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: 08/27/2025
• Device Catalogue Number: RBYPCLP30
• Device Lot Number: F99860
• Was Device Available for Evaluation?: No
• 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: 04/29/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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 Age: 49 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005