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

Catalog Number	RBY2C0435
Medical Device Problem Codes	Separation Failure (2547); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations throughout its length.The embolization coil was detached from the pusher assembly, the pull wire was retracted out of the distal detachment tip (ddt), and the pusher assembly lumen had blood throughout.Conclusions: evaluation of the returned device revealed the pet lock was separated and the embolization coil was detached.A broken pet lock indicates a pull force was applied to the proximal end of the pusher assembly, typically in an attempt to detach the coil with a handle.Patient anatomy tortuosity, blood in the pusher assembly lumen, or kinks in the pusher assembly may cause a build-up of friction inside the pusher assembly hypotube, which can overcome the force able to be applied by the handle.Repositioning of the ruby coil may alleviate some of this tension, and allow the embolization coil to detach.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils 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: 3005168196-2018-00339.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) to treat a gastrointestinal (gi) bleed using ruby coils and a ruby coil detachment handle (handle).During the procedure, the hospital technician was unable to detach a ruby coil using the handle, despite the pet lock on the pusher wire being separated.The physician therefore retracted and removed the ruby coil, and completed the procedure using additional ruby coils 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: 7267956
• Report Number: 3005168196-2018-00312
• Device Sequence Number: 2117128
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2018

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: Radiologic Technologist
• Device Expiration Date: 03/09/2024
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F68394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR