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

Catalog Number	RBYPCLP45
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
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 number: 3005168196-2023-00272 h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the aortopulmonary collateral arteries using packing coil lps, a non-penumbra microcatheter, and a guidewire.During the procedure, while advancing a packing coil lp into the target location, the physician decided to retract and reposition the packing coil lp.Subsequently, upon retracting the packing coil lp, the packing coil lp unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached packing coil lp was removed from the patient and the coil was flushed out of the microcatheter.Then, a second packing coil lp was advanced into the target location and the physician also decided to retract and reposition the second packing coil lp; however, the same issue occurred.Therefore, the microcatheter containing the second detached packing coil lp was removed from the patient and the coil was flushed out of the microcatheter.The procedure was completed using ruby coil lps 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: 17082295
• Report Number: 3005168196-2023-00273
• Device Sequence Number: 2188627
• Product Code: HCG
• UDI-Device Identifier: 00815948021945
• UDI-Public: 815948021945
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2023
• 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: RBYPCLP45
• Device Lot Number: F112161
• 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: 05/16/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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: 7 MO
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005