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

Catalog Number RBY4C1650

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The stretch resistance wire (sr wire) was fractured, the embolization coil was detached from its pusher assembly inside its introducer sheath, and the proximal constraint sphere was inside the distal detachment tip (ddt).The introducer sheath was ovalized approximately 6.0 cm from the distal tip.Conclusions: evaluation of the returned ruby coil revealed that the introducer sheath was ovalized.If the device is retracted out of its packaging hoop at extreme angles, damage such as ovalization may occur.Further evaluation of the returned device revealed that the embolization coil sr wire was fractured.If the embolization coil is forcefully retracted against resistance, damage such as this may occur.The embolization coil being retracted through the damage introducer sheath likely contributed to the sr wire fracture.Penumbra coils 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.

Event Description

During preparation for a coil embolization procedure, the hospital staff found that the introducer sheath of the ruby coil was bent upon removal from the packaging.The damage to the introducer sheath was found prior to use.Therefore, the ruby coil was not used in the procedure.The procedure was completed using a new ruby coil.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7659498
• MDR Text Key: 113256100
• Report Number: 3005168196-2018-01313
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F77224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1