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

Catalog Number	RBY2C0430
Medical Device Problem Codes	Detachment Of Device Component (1104); Unraveled Material (1664); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was detached and unraveled.The pet lock was intact on the proximal end of the ruby coil pusher assembly.The proximal constraint sphere was present inside the distal detachment tip (ddt) and the fractured stretch resistant wire (sr wire) was visible.Conclusions: evaluation of the returned ruby coil revealed a detached embolization coil via sr wire fracture.The detached embolization coil was unraveled.This sr wire fracture is likely a result of retracting the embolization coil against resistance.If the sr wire fractures, the embolization coil will likely detach and any further manipulation of the damaged coil implant may cause it to unravel.Evaluation of the returned lantern delivery microcatheter (lantern) revealed a kink around the mid-shaft of the catheter.It was indicated that the patient anatomy was tortuous.The nature of this kink resembled damage that typically appears as result of the torquing motion.If the catheter was pinned distally in tortuous anatomy and is torqued on the proximal end, damage such as this may occur.If this kink were to occur prior to retracting the embolization coil, this kink would likely contribute to the resistance that eventually resulted in the ruby coil premature detachment via sr wire fracture.The non-penumbra diagnostic catheter mentioned in the complaint was not returned for evaluation.Penumbra catheters and 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: 3005168196-2018-00003.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils and lantern delivery microcatheters (lanterns).It was noted that the patient anatomy was tortuous.During the procedure, while attempting to advance a ruby coil through a lantern, the physician experienced resistance and decided to retract it; however, upon retraction, the ruby coil unintentionally detached inside the lantern and started to come apart in the lantern.Therefore, the physician pulled the lantern out of the patient¿s body with the ruby coil partially in the diagnostic catheter.The ruby coil eventually came back out but had started to unwind.The procedure was completed using a new ruby coil and a new lantern.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: 7158703
• Report Number: 3005168196-2018-00002
• Device Sequence Number: 16168116
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/04/2017

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: 07/23/2025
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F78319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR