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

Catalog Number RBY4C0315

Device Problems Bent (1059); Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results: the ruby coil pusher assembly was kinked approximately 5.0 and 67.0 cm from the proximal end.Conclusions: evaluation of the returned ruby coil revealed two kinks along the pusher assembly length.The proximal kink was likely a result of forcefully removing the ruby coil from the packaging hoop.The more distal of the two kinks was likely due to the returned packing condition.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.

Event Description

During preparation for a coil embolization procedure, the radiologic technologist noticed that the ruby coil pusher assembly was bent/kinked near the pet lock upon removal from the packaging.The damaged ruby coil was found prior to use and therefore, was not used in the procedure.The procedure was completed using another 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: 7084185
• MDR Text Key: 94936229
• Report Number: 3005168196-2017-02127
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F77601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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