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

Catalog Number	RBYPCLP60
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the thyrocervical, left internal mammary artery (lima), and venous collateral using packing coil lps and a non-penumbra microcatheter.During the procedure, while advancing a packing coil lp into the target location, the physician experienced resistance and the microcatheter would kick back out of the vessel.When the physician went to retract the packing coil lp, there was resistance noted and the coil had unintentionally detached inside the microcatheter.The physician removed the microcatheter containing the detached packing coil lp and a new microcatheter was placed in the vessel.Next, while advancing another packing coil lp into the vessel, the physician noticed the packing coil was too stiff.Therefore, the packing coil lp was removed and saved for later to be use in a different vessel.When the physician attempted to reuse the packing coil lp in a different collateral vessel, the physician experienced resistance and the coil would not advance out from its introducer sheath; therefore, the packing coil lp was removed.The physician then advanced a third packing coil lp into the vessel, but the coil was stiff and the microcatheter would kick back out from the vessel.The packing coil lp was removed.The procedure was completed using new non-penumbra coils and the same microcatheter.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 18965627
• Report Number: 3005168196-2024-00101
• Device Sequence Number: 8161632
• Product Code: HCG
• UDI-Device Identifier: 00815948026209
• UDI-Public: 815948026209
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2024
• 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 Catalogue Number: RBYPCLP60
• Device Lot Number: F00008348
• 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: 02/27/2024
• Initial Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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: 4 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005