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

Model Number RBYLP0310

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2021

Event Type  malfunction  

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: 3005168196-2021-01409.

Event 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
• Type of Device: 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: 12063972
• MDR Text Key: 259463099
• Report Number: 3005168196-2021-01410
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021785
• UDI-Public: 00815948021785
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/24/2021

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
• Device Operator: Health Professional
• Device Model Number: RBYLP0310
• Device Catalogue Number: RBYLP0310
• Device Lot Number: F99454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54