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

Catalog Number RBY2C3260

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the third ruby coil evaluated.The embolization coil windings were offset.The embolization coil was intact with its pusher assembly.The outer diameters (od) of the ruby coil was measured and found to be within specification.Conclusions: evaluation of the returned devices revealed that all four ruby coils were advanced out of their introducer sheaths after they were hydrated.These four ruby coils were also advanced through a demonstration rhv and pxslim without an issue.The first and third ruby coils had offset coil windings.This type of damage likely occurred due to forceful handling against resistance.The fourth ruby coil¿s pusher assembly was kinked.This kink was likely incidental and may have occurred during packaging the device for return.The root cause of the reported resistance for all four ruby coils could not be determined.The root cause of the reported resistance for all four ruby coils could not be determined.It should be noted that there were no issues found with the second and fourth returned coils.The damage found to the fourth coil was incidental.Furthermore, the devices passed functional testing without any issues.Therefore, these two coils are not considered reportable.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: 3005168196-2017-00283.

Event Description

The patient was undergoing a coil embolization procedure in the gastric varices using ruby coils.During the procedure, while attempting to advance four ruby coils through the microcatheter, the physician experienced resistance and the coils would not advance past the rotating hemostasis valve (rhv) and into the microcatheter.Therefore, the ruby coils were removed and the procedure was completed using sixteen new ruby coils.It was reported that other ruby coils were successfully deployed and detached into the target vessel prior to the four in complaint.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: 6376340
• MDR Text Key: 69018079
• Report Number: 3005168196-2017-00284
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013107
• UDI-Public: 00814548013107
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F71707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• 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: 44 YR
• Patient Weight: 61