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

Catalog Number	RBY4C0315
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00378.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully detached two ruby coils in the target vessel using the handle.When attempting to detach the third ruby coil using the handle, the ruby coil could not be detached.The ruby coil was therefore removed and was not used in the procedure.The procedure was completed using two additional ruby coils and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken and pull tube was retracted on the proximal end of the pusher assembly.Bends and kinks were present approximately 1.5 cm, 4.5 cm, 19.5 cm, 24.0 cm, 28.5 cm, 43.5 cm, 46.5 cm, 50.5 cm, 58.0 cm, 59.0 cm, 77.0 cm, 85.0 cm and 94.0 cm from the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly with a fractured stretch resistant wire (sr wire) and the proximal constraint sphere was within the distal detachment tip (ddt).The embolization coil had offset coil winds throughout the coil.Conclusions: evaluation of the returned ruby coil revealed a detached embolization coil.The embolization coil was detached due to the stretch resistant (sr) wire being fractured; however, the proximal constraint sphere was intact with the distal detachment tip (ddt) of the pusher assembly and was stuck due to an unknown substance.The pet lock was broken and pull wire was retracted indicating the handle performed as intended; therefore, the unknown substance holding the proximal constraint sphere in the ddt was determined to be the cause of the coil not detaching during the procedure.The embolization coil damage, including the sr component fracture, is likely due to the device being returned unprotected by the introducer sheath and is incidental to the reported complaint.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8377841
• Report Number: 3005168196-2019-00377
• Device Sequence Number: 1288538
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 01/30/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 01/29/2025
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F74102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005