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

Model Number RBYPCLP30

Device Problems Break (1069); Unraveled Material (1664); Physical Resistance/Sticking (4012)

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure to treat a celiac gastrointestinal bleed (gi bleed) using packing coil lp and a non-penumbra microcatheter.During the procedure, the physician advanced a packing coil lp partially into the target location and determined the coil to be too long for the vessel.It was reported that the packing coil lp had not fully exited the microcatheter.Subsequently, the physician decided to remove the packing coil lp; however, upon retracting the packing coil lp, the physician experienced resistance and the packing coil lp broke off and started to unravel within the microcatheter while partially inside the target vessel.It was also reported that the packing coil lp had not detached from the pusher assembly.Therefore, the physician flushed the microcatheter to push the broken portion of the packing coil lp into the vessel.The procedure was completed using additional packing coil lps and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned packing coil lp pusher assembly confirmed that the embolization coil was detached.If the packing coil lp is forcefully retracted against resistance, the pusher assembly may elongate beyond reach of the pull wire and result in the embolization coil detaching from its pusher assembly.The detached embolization coil was not returned for evaluation.The root cause of the resistance could not be determined.Further evaluation revealed a separated pet lock and pusher assembly kinks.This damage is incidental to the reported complaint and the root cause could not be determined.Penumbra products 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: 13253075
• MDR Text Key: 287201963
• Report Number: 3005168196-2022-00012
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021938
• UDI-Public: 00815948021938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPCLP30
• Device Catalogue Number: RBYPCLP30
• Device Lot Number: F98713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• 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
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• 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