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

Catalog Number RBYPCLP15

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.

Event Description

The patient was undergoing a coil embolization procedure to treat an endoleak from the superior mesenteric artery (sma) to the inferior mesenteric artery (ima) using packing coil lps, a ruby coil lp, a lp system detachment handle (handle), and a non-penumbra microcatheter.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician successfully placed a ruby coil lp into the target location using the microcatheter.The physician then advanced a packing coil lp into the target location using the microcatheter and attempted to detach it using the handle; however, the packing coil lp failed to detach.Therefore, the packing coil lp was removed.The physician then advanced another packing coil lp into the target location using the microcatheter and attempted to detach it using the same handle; however, the packing coil lp failed to detach.Therefore, the physician decided to remove the packing coil lp.While retracting the packing coil lp, it unintentionally detached.The physician then injected saline into the microcatheter and successfully implanted the detached packing coil lp into the target location.The procedure was completed using the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2024-00034.Section d.Box 4.Lot #; section d.Box 4.Catalog #; section d.Box 4.Expiration date; section d.Box 4.Unique identifier; section h.Box 4.Device manufacture date.Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 3005168196-2024-00034.Section d.Box 6.If implanted, give date.Evaluation of the returned packing coil lp pusher assembly confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull wire was retracted from the pusher assembly distal tip.If the pet lock is separated and the pull wire is retracted from the pusher assembly, the embolization coil will detach from the pusher assembly.The separated pet lock was likely due to the coil detachment attempted during the procedure.It was reported that the detached embolization coil was implanted into the target location by injecting saline into the microcatheter.Further evaluation revealed kinks along the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.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
• Type of Device: 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: 18607548
• MDR Text Key: 334106460
• Report Number: 3005168196-2024-00034
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021921
• UDI-Public: 815948021921
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: RBYPCLP15
• Device Lot Number: F00006428
• 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Male