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

Catalog Number RBY4C0860

Device Problems Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the embolization coil sr wire was fractured and the proximal constraint sphere was missing.The ruby coil was stretched and unraveled on the proximal end of the embolization coil.The pet bump was pushed distal to the alignment feature of the distal detachment tip (ddt).The pet lock was intact on the pusher assembly.The pusher assembly had bends along the length of the device.Conclusions: evaluation of the returned lantern revealed an ovalized region on the distal length of the catheter.This damage may have occurred due to forceful manipulation of the device during navigation of difficult patient anatomy.It was reported the lantern was advanced through patient anatomy without a guidewire.If the lantern is not advanced over a guidewire during the procedure, there is a higher likelihood of this distal catheter damage occurring.The reported kinks could not be confirmed.The first evaluated ruby coil had a kinked pusher assembly.If the pusher assembly is forcefully advanced through a damaged catheter, damage such as this may occur.The ovalized region on the lantern likely contributed to the inability to advance the ruby coil during the procedure.Further evaluation revealed that the sr wire was fractured.This damage was not mentioned in the reported complaint and the embolization coil was returned inside the introducer sheath.Therefore, it is likely the sr wire became fractured post-procedure and was incidental to the reported failure.The second evaluated ruby coil had a kinked pusher assembly.If the pusher assembly is forcefully advanced against resistance, damage such as this may occur.If the delivery catheter is retracted into the parent device for any reason while the embolization coil is advanced out of delivery catheter, the embolization coil may take shape within the parent device.If the embolization coil were to take shape within the parent device, difficulty advancing and retracting the coil may result.The root cause of the reported microcatheter complaint was unable to be determined.Further evaluation revealed the ruby coil sr wire was fractured and the embolization coil was stretched and unraveled.The reported complaint identified that once the guide catheter was embolized, the non-penumbra guide catheter and microcatheter, and ruby coil were removed successfully.Based on the returned condition and the reported complaint, the sr wire fracture and embolization coil damage are likely incidental to the complaint and may have occurred during removal of the embolization coil from the non-penumbra catheter and guide catheter post-procedure.Penumbra coils and catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.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 numbers: 3005168196-2018-01336, 3005168196-2018-01337.

Event Description

The patient was undergoing a coil embolization procedure to treat a pelvic congestion using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a lantern through a non-penumbra guide catheter with no guidewire, then attempted to advance a ruby coil through the lantern; however, the ruby coil would not advance beyond the tip of the lantern.Subsequently, the ruby coil pusher assembly became kinked and therefore, the ruby coil was removed.It was reported that the end of the lantern appeared to be kinked when the lantern was removed.The physician continued the procedure using another microcatheter and additional ruby coils and pod packing coils (podjs).While advancing a new ruby coil through the microcatheter towards the middle of the procedure, the microcatheter kicked back into the guide catheter and consequently, the ruby coil embolized the tip of the guide catheter.Therefore, the guide catheter, microcatheter and the ruby coil were removed altogether.The procedure was completed using the same guide catheter, microcatheter and some podjs.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• 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: 7664599
• MDR Text Key: 113287985
• Report Number: 3005168196-2018-01338
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F73514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2017
• 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: 42 YR