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

Model Number	RBYPCLP03
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
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.This report is associated with mfr report numbers: 3005168196-2021-01838, 3005168196-2021-01839, 3005168196-2021-01841, 3005168196-2021-01842, 3005168196-2021-01843, 3005168196-2021-01844.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a collateral of the internal iliac artery using packing coil lps, ruby coil lps, lp system detachment handles (handle), a non-penumbra coil, a non-penumbra microcatheter and a guidewire.It was noted that the patient¿s anatomy was very tortuous.During the procedure, the physician advanced a packing coil lp into the target vessel using the microcatheter and attempted to detach it using a handle.However, the packing coil lp failed to detach.Therefore, the packing coil lp was retracted and removed.Subsequently, the same issue occurred with another packing coil lp.Therefore, the packing coil lp was also removed.Then, the physician advanced the next packing coil lp into the target vessel and attempted to detach it using the handle; however, the packing coil lp failed to detach.Therefore, the physician manually detached the packing coil lp using a surgical clamp.Next, the physician successfully implanted a non-penumbra coil in the target vessel.The physician then advanced a ruby coil lp into the target vessel and attempted to detach it using a second handle; however, the ruby coil lp failed to detach.Therefore, the physician manually detached the ruby coil lp using a surgical clamp.Subsequently, the same issue occurred with another ruby coil lp.Therefore, the physician also manually detached the ruby coil lp using a surgical clamp.While attempting to detach the next ruby coil lp in the target vessel, the ruby coil lp unintentionally detached in the microcatheter.Subsequently, the physician used saline injection to push the detached coil into the target location.The physician then successfully implanted the last ruby coil lp in the target vessel using the second handle.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report.1.Section d.Box 6.If implanted, give date.This report is associated with mfr report numbers: 3005168196-2021-01838, 3005168196-2021-01839, 3005168196-2021-01841, 3005168196-2021-01842, 3005168196-2021-01843, 3005168196-2021-01844 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12344000
• Report Number: 3005168196-2021-01840
• Device Sequence Number: 19818070
• Product Code: HCG
• UDI-Device Identifier: 00815948021891
• UDI-Public: 00815948021891
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021
• 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: 10/14/2025
• Device Model Number: RBYPCLP03
• Device Catalogue Number: RBYPCLP03
• Device Lot Number: F101115
• 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: 07/26/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005