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

Catalog Number RBY4C2060

Device Problem Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

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.This report is associated with mfr report numbers: 3005168196-2018-00687, 3005168196-2018-00688, 3005168196-2018-00690, 3005168196-2018-00691, 3005168196-2018-00692.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the subclavian artery using ruby coils, pod packing coils (podj¿s) and a lantern delivery microcatheter (lantern).During the procedure, while attempting to place the first ruby coil in the target vessel using a lantern, the physician determined that the coil was oversized and decided to remove it; however, the ruby coil pusher assembly was accidentally kinked while re-sheathing the ruby coil.The physician then had difficulty advancing the second ruby coil through the lantern, and mentioned that the ruby coil felt gritty and therefore it was removed.It was also reported that there was a lot of blood in the coil¿s introducer sheath.The physician then successfully deployed and detached the third ruby coil.While attempting to advance the fourth ruby coil through the lantern, the ruby coil felt gritty and a lot of blood was also noticed in the coil's introducer sheath; therefore, it was removed.Thereafter, the physician successfully deployed and detached the fifth, sixth and seventh coil in the target vessel.While attempting to advance the eighth and ninth coils (podj¿s) through the lantern, the physician experienced resistance and the coils would not advance; therefore, they were both removed.At this point, it was suspected that the lantern had a kink; therefore, the lantern was removed.Upon removal of the lantern, the kink was confirmed.The procedure was completed using a new lantern, additional ruby coils and pod packing coils.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: 7396518
• MDR Text Key: 104437155
• Report Number: 3005168196-2018-00689
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY4C2060
• Device Lot Number: C05008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• 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: 63 YR