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

Catalog Number RBY2C0430

Device Problems Failure to Advance (2524); Physical Resistance (2578); Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly of the first ruby coil evaluated.The pusher assembly was fractured approximately 93.5 cm from the proximal end.The embolization coil was detached from its pusher assembly.The proximal constraint sphere was on the proximal end of the embolization coil.The outer diameter (od) of the embolization coil was measured and found to be within specification.Conclusions: evaluation of the first ruby coil revealed that the pusher assembly was fractured.This damage likely occurred due to forceful handling during use.Further evaluation of the first returned ruby coil revealed that the embolization coil was detached from its pusher assembly.The fractured pusher assembly and the separation of the two fractured segments likely allowed the pull wire to retract out of the ddt, which would detach the embolization coil from its pusher assembly.The od of the embolization coil was measured and found to be within specification.Evaluation of the second returned ruby coil revealed that the stretch resistant (sr) wire was fractured and the embolization coil was detached.Sr wire fracture typically occurs due to forceful retraction against resistance, and will allow the embolization coil to detach from the pusher assembly.Further evaluation of the returned device revealed that the pusher assembly was kinked.This damage was likely incidental and may have occurred while packaging the device for return.The root cause of the reported resistance could not be determined.The embolization coil to the second ruby coil and the non-penumbra microcatheter mentioned in the complaint were not returned for evaluation.Penumbra coils 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 number: 3005168196-2017-00526.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.It was reported that the patient's anatomy was tortuous.During the procedure, after advancing an initial ruby coil half way through the non-penumbra microcatheter, the physician encountered resistance and was unable to advance the coil further.Therefore, the ruby coil was retracted and the microcatheter was flushed.The physician then attempted to advance a second ruby coil; however, the same issue occurred and the ruby coil was removed.The procedure was completed using the same microcatheter and additional coils.The physician believes that the tortuosity of the vessel caused the microcatheter to become ovalized and cinch down on the ruby coils, which was why they were unable to be advanced.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: 6457854
• MDR Text Key: 71838122
• Report Number: 3005168196-2017-00525
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F71688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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: 72 YR