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

Catalog Number RBY2C0512

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact.The pusher assembly was kinked approximately 5.0 cm, 13.0 cm, 17.0 cm, 47.0 cm, 54.0 cm, 82.0 cm, and 100.0 cm from the proximal end.The coil was intact with the pusher assembly, and compressed distally away from the proximal constraint sphere.The pet lock was intact.The coil was intact with the pusher assembly, and compressed distally away from the proximal constraint sphere.Conclusion: the complaint has been evaluated.The initial complaint indicated that the ruby coils were advanced through a 5f diagnostic catheter and met resistance.This type of failure typically occurs due to improper handling during use.If the ruby coil is attempted to be advanced through a catheter other than a 0.025" microcatheter, it is likely that delivery of the coil through the catheter will fail.Evaluation of the returned devices revealed that the coils of both ruby coils were compressed distally away from the proximal constraint sphere.This type of damage typically occurs due to withdrawing the coil into the introducer sheath against resistance.This may cause the coils to become offset, increasing the outer diameter of the coil.If the coil is compressed it will likely cause difficulty manipulating the coils.[-1] the kinks along the pusher assembly of the first ruby coil evaluated were likely due to improper return packaging.These devices are 100% visually and functionally evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2015-00895.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician met resistance while advancing a ruby coil through another manufacturer's diagnostic catheter and it was removed.While advancing a new ruby coil through the diagnostic catheter the physician met resistance again and removed the ruby coil.The procedure continued using another manufacturer's system.There was no report of an adverse effect on the patient.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5072253
• MDR Text Key: 25627679
• Report Number: 3005168196-2015-00894
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012896
• UDI-Public: 00814548012896
• 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
• Report Date: 08/14/2015

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
• Device Operator: Physician
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: RBY2C0512
• Device Lot Number: F62606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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
• Patient Age: 57 YR