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

Catalog Number RBY2C1660

Device Problems Failure to Advance (2524); Device Damaged by Another Device (2915); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the renal artery using ruby coils.It was noted that the patient's anatomy was tortuous.During the procedure, the physician had a little bit of difficulty advancing the initial ruby coils through the non-penumbra microcatheter but was able to successfully deploy and detach the coils into the target vessel.While attempting to advance a new ruby coil through the same microcatheter, the physician did not mention experiencing any resistance; however, the coil became stuck.It was then observed that the microcatheter had become ovalized due to the patient's tortuous anatomy.Therefore, the microcatheter containing the ruby coil was removed.The physician then decided to end the procedure because the existing packing density was sufficient.It was reported that the physician had difficulty advancing the initial ruby coils due to the ovalized microcatheter and that the ovalized microcatheter also caused the last ruby coil to become stuck within the microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The pet lock was kinked and broken, but the pull tube was not retracted.The embolization coil had offset coil winds along its length.The pusher assembly was kinked in multiple locations along its length.The embolization coil was intact with the pusher assembly and the coil was compressed.During functional analysis, the ruby coil was retracted into its introducer sheath but was unable to be advanced back out.Evaluation of the returned ruby coil revealed offset coil winds and compression on the embolization coil.It was reported the non-penumbra microcatheter was ovalized due to tortuous patient anatomy.It is likely that repeated manipulation through the ovalized catheter resulted in the observed offset coil winds and compression.These damage likely contributed to the embolization coil becoming stuck inside the non-penumbra catheter.Further evaluation revealed kinks along the length of the catheter.These kinks were likely incidental and occurred during packaging for return to penumbra.The non-penumbra catheter cited in the complaint was not returned for evaluation.Penumbra coils are 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.

• 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: 6899004
• MDR Text Key: 88798436
• Report Number: 3005168196-2017-01623
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F71427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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