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

Catalog Number	RBY4C0201
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure treating a gastrointestinal bleeding (gi bleed) using ruby coils.During the procedure, the physician successfully deployed and detached a coil in the target vessel using another manufacturer¿s microcatheter.While attempting to advance a ruby coil through the same microcatheter, the ruby coil became stuck around the rotating hemostasis valve (rhv) and the proximal end of the microcatheter.Therefore, the microcatheter was removed with the ruby coil still stuck inside.The physician then took additional pictures and saw that the bleeding had stopped; therefore, the procedure was ended at this point.There was no report of an adverse effect to the patient.
Additional 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.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure treating a gastrointestinal bleeding (gi bleed) using ruby coils.During the procedure, the physician successfully deployed and detached a ruby coil in the target vessel using another manufacturer¿s microcatheter.While attempting to advance a ruby coil through the same microcatheter, the physician experienced resistance and the ruby coil became stuck around the rotating hemostasis valve (rhv) and the proximal end of the microcatheter.Therefore, the microcatheter was removed with the ruby coil still stuck inside.The physician then took additional pictures and saw that the bleeding had stopped; therefore, the procedure was ended at this point.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: 6332141
• Report Number: 3005168196-2017-00216
• Device Sequence Number: 11004978
• Product Code: HCG
• UDI-Device Identifier: 00814548013114
• UDI-Public: 00814548013114
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2017

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: 09/17/2024
• Device Catalogue Number: RBY4C0201
• Device Lot Number: F71620
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1