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	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked approximately 145.0 cm from the proximal end.The embolization coil was intact with the pusher assembly, the pull wire was inside the distal detachment tip (ddt), and dried blood occluded the interior of the ddt.Conclusions: evaluation of the returned device revealed that the ddt was occluded with dried blood.When the pull wire was manually retracted during functional testing, dried blood prevented the proximal constraint sphere from releasing out of the ddt, which prevented the embolization coil from detaching.If continuous flush is not used during the procedure, dried blood may be more likely to occlude the ddt.Further evaluation revealed that the pusher assembly was kinked.This damage may have occurred due to forceful manipulation during positioning within patient anatomy.The ruby coil¿s introducer sheath, the handle and lantern mentioned in the complaint were not returned for evaluation.Penumbra coils and catheters 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: 3005168196-2017-01825.
Event or Problem Description
The patient was undergoing a coil embolization to treat a gastrointestinal (gi) bleed using ruby coils.During the procedure, the physician successfully deployed and detached initial ruby coils into the target vessel using a lantern delivery microcatheter (lantern) and a ruby coil detachment handle (handle).The physician then deployed a new ruby coil into the target vessel and attempted to detach it using the same handle; however, the ruby coil failed to detach.After multiple failed attempts, the ruby coil was removed.The procedure was successfully completed using a new ruby coil, the same lantern and the same handle.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: 6966357
• Report Number: 3005168196-2017-01824
• Device Sequence Number: 19213171
• 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): 09/25/2017

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: 05/15/2025
• Device Catalogue Number: RBY4C0202
• Device Lot Number: F77138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR