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

Model Number	RBYPCLP06
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The patient was undergoing a coil embolization procedure to treat a retroperitoneal bleed using packing coil lp and a non-penumbra microcatheter.During the procedure, while advancing a packing coil lp as the first coil through the microcatheter, the packing coil lp had unintentionally detached early in the microcatheter.Subsequently, the physician used the pusher assembly to push the detached packing coil lp into the target location.The procedure was completed using additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
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 had slipped allowing the pull wire to be retracted without breaking the pet lock.If the pull wire is retracted, the embolization coil will detach.The root cause of the pull wire slipping could not be determined.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the unintentional detachment.H3 other text: placeholder.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12374941
• Report Number: 3005168196-2021-01901
• Device Sequence Number: 19817153
• Product Code: HCG
• UDI-Device Identifier: 00815948021907
• UDI-Public: 00815948021907
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 08/26/2021
• 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: 02/11/2025
• Device Model Number: RBYPCLP06
• Device Catalogue Number: RBYPCLP06
• Device Lot Number: F96275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005