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

Catalog Number	RBY2C0415
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2017-00471.
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 successfully placed multiple coils.The physician then attempted to place a ruby coil and, after successfully advancing the ruby coil through another manufacturer¿s microcatheter, the ruby coil was unable to detach using the handle.However, the physician reported that the detachment zone had separated.The ruby coil then detached within the microcatheter; therefore, the microcatheter was removed with the ruby coil inside.The procedure was completed using a new handle, a new ruby coil, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was broken on the proximal end of the ruby coil pusher assembly.The pull wire was completely retracted out of its pusher assembly.The inner diameter (id) of the distal detachment tip (ddt) was measured and found to be within specification.Conclusion: evaluation of the returned devices revealed that the pull wire was retracted out of the ruby coil¿s pusher assembly and the embolization coil was detached.It is likely that friction between the pull wire and the hypotube inner lumen may have contributed to inability to detach the embolization coil.Extreme tortuosity along the majority length of the pusher can cause a build-up of friction between the pull wire and the inner pusher tube, overcoming the force that the handle is able to apply.Withdrawing the coil will alleviate some of the friction, and the tension in the pull wire may cause the coil to detach.The id of the ddt was measured and found to be within specification.Further evaluation of the returned devices revealed no visible damage to the handle and, the handle was functional.The handle was functionally tested using the handle fixture and was within specification.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6442854
• Report Number: 3005168196-2017-00470
• Device Sequence Number: 1042103
• Product Code: HCG
• UDI-Device Identifier: 00814548012858
• UDI-Public: 00814548012858
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2017

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: 06/27/2024
• Device Catalogue Number: RBY2C0415
• Device Lot Number: F70362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR