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

Catalog Number	RBYPCLP30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 in the gastroduodenal artery (gda) using packing coil lps and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted two ruby coil lps.After advancing a packing coil lp into the target location, the physician reported that the coil was not taking its intended shape and felt that the packing coil lp might have been too long.While retracting the packing coil lp, the coil unintentionally detached when it was partially in the vessel and partially in the microcatheter.Therefore, the physician used a snare device to remove the packing coil lp.The procedure was completed using a shorter packing coil lp and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, a device investigation could not be performed.Without the return of the device, the root cause of the problem could not be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.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: 18116730
• Report Number: 3005168196-2023-00508
• Device Sequence Number: 12640532
• Product Code: HCG
• UDI-Device Identifier: 00815948021938
• UDI-Public: 815948021938
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023
• 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: RBYPCLP30
• Device Lot Number: F00006669
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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: 57 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005