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

Catalog Number	RBYPCLP60
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
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: 3005168196-2022-00550, 3005168196-2022-00551.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the collateral artery using packing coil lps, pod packing coils (pod pc), and a non-penumbra microcatheter.During the procedure, the physician attempted to advance a pod pc into the vessel; however, the pod pc was determined to be too large and would not pack in the vessel.After making a second attempt to advance the coil, the physician decided to remove the pod pc.However, while retracting, the pod pc had unintentionally detached inside the microcatheter.Therefore, the physician used a snare device to remove the detached pod pc.The physician then attempted to advance the next packing coil lp into the vessel, but the coil was determined to be the wrong size and would not advance into the vessel.Subsequently, while retracting, the packing coil lp detached inside the microcatheter.Therefore, the physician used a syringe to aspirate the detached packing coil lp out of the microcatheter.The same issue then occurred with the next packing coil lp and the physician removed the detached packing coil lp using a syringe.It was also reported that the microcatheter was also removed.The procedure was completed using new smaller size packing coil lp and a new smaller size 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: 15846282
• Report Number: 3005168196-2022-00552
• Device Sequence Number: 5981494
• Product Code: HCG
• UDI-Device Identifier: 00815948021952
• UDI-Public: 815948021952
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/22/2022
• 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 Catalogue Number: RBYPCLP60
• Device Lot Number: F113174
• 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: 11/03/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: 6 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005