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

Model Number	RBYPCLP15
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
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: 3005168196-2022-00085, 3005168196-2022-00086.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type 2 endoleak in the inferior mesenteric artery (ima) using packing coil lps, ruby coil lps, an lp system detachment handle (handle), a non-penumbra microcatheter, a 6fr non-penumbra sheath, and a diagnostic catheter.During the procedure, the sheath and diagnostic catheter were advanced into the superior mesenteric artery (sma), and the physician obtained access to the endoleak through the ima using the microcatheter.Then, the physician advanced a packing coil lp to the target vessel using the microcatheter and attempted to detach it using the handle; however, the coil failed to detach.The physician pulled the pusher assembly of the packing coil lp further back in an attempt to detach the coil; however, the attempt was unsuccessful.Therefore, the physician decided to retract the packing coil lp.While retracting the packing coil lp approximately halfway back through the microcatheter, the packing coil lp unintentionally detached in the microcatheter.The physician then flushed the detached packing coil lp out of the microcatheter and into the target location using a 1cc syringe and, subsequently, the packing coil lp was implanted successfully.Next, the same issue occurred with two additional packing coil lps.The physician then also flushed the detached packing coil lps out of the microcatheter and into the target location using a 1cc syringe, and the packing coil lps were implanted successfully.Next, a ruby coil lp was advanced to the target location using the microcatheter, and the physician attempted to detach it using the handle; however, the ruby coil lp failed to detach.Therefore, the ruby coil lp was removed intact.The procedure was completed using four additional ruby coil lps and the same handle and 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: 13635108
• Report Number: 3005168196-2022-00084
• Device Sequence Number: 5076495
• Product Code: HCG
• UDI-Device Identifier: 00815948021921
• UDI-Public: 00815948021921
• Combination Product (Y/N): N
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2022
• 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: 04/13/2026
• Device Model Number: RBYPCLP15
• Device Catalogue Number: RBYPCLP15
• Device Lot Number: F105416
• 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: 01/31/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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 Sex: Male
• Date Report Sent to FDA: 01/01/2005