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

Catalog Number	RBY2C0305-A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2016
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a gastrointestinal (gi) bleed using ruby coils.During the procedure, the physician successfully deployed and detached ruby coils into the target vessel using a ruby coil detachment handle (handle).After deploying a new ruby coil into the patient, the physician used the same handle to detach the coil.However, upon removal of the ruby coil pusher assembly from the handle, the physician noticed that the ruby coil was still attached to the pusher assembly and did not attach in the patient.The procedure was successfully completed using a new ruby coil and the same handle.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.Upon first evaluation, the embolization coil was intact with the pusher assembly.After 30 minutes of decontamination, the embolization coil was noticed to be detached from the pusher assembly.Blood was observed inside the distal detachment tip.Conclusion: evaluation of the returned device revealed the pet lock was broken, indicating a pull force was applied to the proximal end of the pull wire, likely in an attempt to detach the ruby coil.Further evaluation revealed the embolization coil was intact with the pusher assembly prior to decontamination, but after 30 minutes of decontamination, the embolization coil was noticed to be detached.The presence of coagulated blood inside the distal detachment tip (ddt) may have caused the proximal constraint sphere to become stuck, and may have prevented the embolization coil from detaching.The handle mentioned in the complaint was not returned for evaluation.Ruby coils are 100% functionally tested during in-process inspection.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: 5743381
• Report Number: 3005168196-2016-00850
• Device Sequence Number: 13663661
• Product Code: HCG
• UDI-Device Identifier: 00814548012810
• UDI-Public: 00814548012810
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 05/23/2016

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: 03/09/2024
• Device Catalogue Number: RBY2C0305-A
• Device Lot Number: F68389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2016
• Supplement Report FDA Received Date: 08/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR