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

Catalog Number	RBY2C0312
Medical Device Problem Codes	Detachment Of Device Component (1104); Inadequacy of Device Shape and/or Size (1583); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from its pusher assembly and the pull wire was advanced distally past the distal detachment tip (ddt).The inner diameter (id) of the ddt and outer diameter (od) of the pull were measured and found to be within specification.Conclusions: evaluation of the first ruby coil revealed that the embolization coil was detached and the pull wire was advanced distally past the ddt.If the device is forcefully retracted against resistance, the pusher assembly may elongate enough so that the pull wire will retract from the ddt effectively detaching the coil.The pull wire and ddt were measured to be within specification.The embolization coil was not returned so the proximal constraint sphere could not be measured.Evaluation of the second ruby coil revealed that the stretch resistant wire (sr wire) was fractured.If the device is forcefully retracted against resistance, damage such as this may occur.The root cause of resistance could not be determined.The lantern identified in the complaint was used to complete the procedure, but was not returned for evaluation.Therefore, the root cause of the resistance contributing to the reported failures could not be determined.Penumbra coils and catheters are visually 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: 3005168196-2018-00977.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician retracted to remove a ruby coil from a lantern delivery microcatheter because the ruby coil was the wrong size.However, upon retraction, the physician felt resistance and the ruby coil unintentionally detached.The lantern was therefore removed with the ruby coil inside.The physician then reinserted the same lantern; however, the same issue occurred with another ruby coil.The procedure was completed using a new ruby coil and the same microcatheter.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: 7504672
• Report Number: 3005168196-2018-00976
• Device Sequence Number: 19285873
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/12/2018

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: Physician
• Device Expiration Date: 11/18/2025
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F80629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 57