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

Model Number	RBYLP0310
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
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 number: 3005168196-2022-00146.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) to treat a gastrointestinal (gi) bleed using packing coil lps, ruby coil lps and a non-penumbra microcatheter.During the procedure, the physician placed a ruby coil lp in the target location using the microcatheter.Next, while attempting to advance the packing coil lp, the physician felt the packing coil lp to be stiff and kicking back and was unable to pack it in the target vessel.Subsequently, the packing coil lp unintentionally detached, and the physician tried to push the packing coil lp using the pusher assembly; however, the attempt was unsuccessful.The packing coil lp then dislodged the previously placed ruby coil lp and the ruby coil lp migrated into a small vessel in the superior mesenteric artery.The packing coil lp was left partially in the target vessel and partially in the common hepatic artery.Attempts were made to retrieve the packing coil lp and ruby coil lp by using a snare device without success.The physician also tried using a balloon to push the coils into the target vessel; however, it was unsuccessful.It was reported that the bleeding had stopped, and no additional coils were required.The procedure ended at this point.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14018079
• Report Number: 3005168196-2022-00145
• Device Sequence Number: 4558987
• Product Code: HCG
• UDI-Device Identifier: 00815948021785
• UDI-Public: 00815948021785
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/05/2022
• 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 Model Number: RBYLP0310
• Device Catalogue Number: RBYLP0310
• Device Lot Number: F110685
• 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: 03/10/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005