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

Catalog Number	RBYLP0630
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) and the gastroepiploic artery (gea) using ruby coil lps, a packing coil lp, a lp system detachment handle (lp handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully implanted three ruby coil lps into the target vessel using the lp handle.The physician then advanced another ruby coil lp into the target vessel; however, the physician decided to retract the ruby coil lp back into the microcatheter to reposition it.While retracting, the ruby coil lp unintentionally detached and migrated distally into the left gastroepiploic artery (lgea).The ruby coil lp was left in the area it had migrated to.The physician then implanted three additional ruby coil lps into the target vessel using the lp handle.Next, the physician advanced a packing coil lp into the target vessel using the microcatheter and attempted to detach it using the lp handle.However, the packing coil lp failed to detach.It was reported that the physician pulled the trigger of the lp handle back and saw the two markers indicating that the packing coil lp had detached.However, when the physician retracted the pusher assembly back through the microcatheter, the packing coil lp was still attached to its pusher assembly.After several attempts the physician successfully detached the packing coil lp using the lp handle and flushed the detached packing coil lp into the target vessel using a saline solution.It was also reported that it took several attempts to detach several of the coils using the lp handle.The procedure was completed using two additional ruby coil lps, the same lp handle, and microcatheter.There was no report of an adverse event to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated for clarification: 1.Section b box 5.Describe event or problem this report is associated with mfr report number: 3005168196-2022-00220.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) and the gastroepiploic artery (gea) using ruby coil lps, a packing coil lp, a lp system detachment handle (lp handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully implanted three ruby coil lps into the target vessel using the lp handle.The physician then advanced another ruby coil lp into the target vessel; however, the physician decided to retract the ruby coil lp back into the microcatheter to reposition it.While retracting, the ruby coil lp unintentionally detached and migrated distally into the left gastroepiploic artery (lgea).The ruby coil lp was left in the area it had migrated to.The physician then implanted three additional ruby coil lps into the target vessel using the lp handle.Next, the physician advanced a packing coil lp into the target vessel using the microcatheter and attempted to detach it using the lp handle.However, the packing coil lp failed to detach.It was reported that the physician pulled the trigger of the lp handle back and saw the two markers indicating that the packing coil lp had detached.However, when the physician retracted the pusher assembly back through the microcatheter, the packing coil lp was still attached to its pusher assembly.After several attempts the physician successfully detached the packing coil lp using the lp handle and flushed the detached packing coil lp into the target vessel using a saline solution.The procedure was completed using two additional ruby coil lps, the same lp handle, and microcatheter.It was reported that it took several attempts to detach all the coils using the lp handle, except for the fourth coil.There was no report of an adverse event 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: 14402748
• Report Number: 3005168196-2022-00214
• Device Sequence Number: 17517901
• Product Code: HCG
• UDI-Device Identifier: 00815948021860
• UDI-Public: 815948021860
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022
• 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 Expiration Date: 06/28/2026
• Device Catalogue Number: RBYLP0630
• Device Lot Number: F107388
• 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: 04/22/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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 Age: 81 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005