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

Catalog Number	RBY4C0202
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly, the proximal segment of the pet lock was separated from the pull tube, and the pull tube and pull wire were retracted out of the pusher hypotube.The embolization coil was detached from the pusher assembly and the distal end of the pull wire was retracted out of the distal detachment tip (ddt).Blood was observed in the pusher assembly hypotube.The outer diameter (od) of the proximal constraint sphere and pull wire, and the inner diameter (id) of the distal detachment tip (ddt) were measured and found to be within specification.Conclusions: evaluation of the returned device revealed the pet lock was broken, the distal end of the pull wire was retracted out of the ddt, and the embolization coil was detached.A broken pet lock indicates that a pull force was applied to the proximal end of the pusher assembly, typically in an attempt to detach the embolization coil.Since the embolization coil was returned detached, and the critical dimensions were measured to be within specification, the root cause of the inability to detach the ruby coil could not be determined.Further evaluation revealed the proximal segment of the pet lock was separated from the pusher assembly.The separation of the proximal segment was likely incidental and may have occurred when the pull tube was fully retracted out of the pusher hypotube.The rh1 mentioned in the complaint was not returned for evaluation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually and functionally inspected during incoming quality inspection.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: 3005168196-2017-01082.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a ruby coil detachment handle (rh1).During the procedure, the physician was unable to detach a ruby coil using a rh1; therefore, the ruby coil was removed.The procedure was completed using a different coil.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6688066
• Report Number: 3005168196-2017-01081
• Device Sequence Number: 10800637
• Product Code: HCG
• UDI-Device Identifier: 00814548013121
• UDI-Public: 00814548013121
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2017

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: 04/11/2025
• Device Catalogue Number: RBY4C0202
• Device Lot Number: F75596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1