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

Catalog Number	RBY2C0312
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil pusher assembly was kinked along its length.The pet lock was separated on the proximal end of the pusher assembly, and the pull wire was kinked.The embolization coil was intact with the pusher assembly at the distal detachment tip (ddt).Coagulated blood and a clear gummy substance was observed in and around the ddt and proximal constraint sphere.During decontamination, the embolization coil became detached from the pusher assembly.The proximal constraint sphere outer diameter (od) and the ddt¿s inner diameter (id) were measured and found to be within specification.The pull wire was accidentally fractured on the proximal end by the penumbra investigator.Conclusions: evaluation of the returned device revealed the pet lock was broken, but the embolization coil was intact with the pusher assembly.The broken pet lock indicates an attempt to detach the coil was made.Further evaluation revealed a substantial amount of coagulated blood and a clear gummy substance in and around the ddt and proximal constraint sphere.Although the embolization coil was received intact with the pusher assembly, during decontamination the embolization coil detached from the pusher assembly.This suggests that the presence of coagulated blood and contrast residue inside the ddt may have contributed to the difficulty of the embolization coil detaching from the pusher assembly.Further evaluation revealed the pusher assembly was kinked in multiple locations.This damage is likely incidental and may have occurred during packaging for return to penumbra facilities.The handle mentioned 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.This report is associated with mfr report number: 3005168196-2017-00847.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician deployed a ruby coil into the target vessel and then attempted to detach the coil using the handle but was unable to do so.It is unknown how the procedure was completed or if there was an adverse effect to the patient.It should be noted that the manufacturer made three attempts to reach out to the customer for additional information; however, no additional information has been obtained.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6607007
• Report Number: 3005168196-2017-00846
• Device Sequence Number: 628605
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/13/2025
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F74974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1