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

Model Number	RBYLP0310
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
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 number: 3005168196-2021-01410.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lateral thoracic artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, the physician placed the ruby coil lp in the target location using the microcatheter.Subsequently, while attempting to advance another ruby coil lp through the introducer sheath, the physician experienced resistance.The physician resheathed the ruby coil lp and tried advancing it; however, he felt resistance again.Therefore, the ruby coil lp was removed.Next, the physician decided to use another ruby coil lp and was able to deploy 90% of the ruby coil lp in the target location; however, he felt resistance and decided to adjust the microcatheter.He felt more resistance and hence decided to remove the ruby coil lp.While retracting, the ruby coil lp broke; however the coil that was deployed was sufficient for the procedure.The procedure was completed by leaving the deployed coil in the target vessel and it was the last coil used in the procedure.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12063971
• Report Number: 3005168196-2021-01409
• Device Sequence Number: 11729949
• Product Code: HCG
• UDI-Device Identifier: 00815948021785
• UDI-Public: 00815948021785
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2021
• 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: 03/02/2025
• Device Model Number: RBYLP0310
• Device Catalogue Number: RBYLP0310
• Device Lot Number: F96642
• Was Device Available for Evaluation?: No
• 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: 05/28/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54
• Date Report Sent to FDA: 01/01/2005