MAUDE Adverse Event Report: COOK INC RETRACTA DETACHABLE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: standard non-hc catheter cobra (cordis).Pma/510(k) #: k151676.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a retracta detachable embolization coil was used on a female patient for an ovarian vein embolization procedure.Three retracta detachable coils were deployed without incident.The user then deployed an additional retracta detachable embolization coil was unable to detach the coil in spite of following the included instructions for use (ifu) provided by manufacturer.After multiple attempts the coil detached; however, upon further inspection it was noted the inconel junction was also detached and could be seen with imaging in the patient.As reported the provider used 3 additional coils higher up in the vein successfully.Per the user, he is satisfied ¿if the inconel junction moves, it will move into the coiling basket higher up, so is not concerned with patient experiencing adverse event.The procedure was completed successfully.The remaining section of complaint device has been collected for investigation and will be forwarded to the manufacturer to aid in the investigation.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, quality control, and specifications of the device, as well as a visual inspection and functional test, were conducted during the investigation.The visual inspection of the complaint device system had no coil attached and was severely elongated and separated at the distal end on the end coil.The unused retracta system was able to deploy the coil successfully, with no damage noted to either the coil or the delivery system.At this time, there is no evidence suggesting that the device used was manufactured out of specification.Additionally, a document based investigation evaluation was performed for lot 8759251.It should be noted there are no records of nonconformances relevant to the reported failure mode and found no additional complaints from the field.It was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu) provides specific instructions for detaching the coil, including that the junction between the coil and delivery wire should remain just inside the tip of the catheter and that the first coil should be sized such that the diameter is 20% larger or 2 mm oversized than the vessel that is being occluded.The instructions for use (ifu) specifies 8-10 counterclockwise turns to detach the coil.Based on the information provided, and the results of the investigation, a definitive cause could not be established.It is possible that the torque device provided with the retracta system was not secured on the wire, losing all torquability.This would cause the retracta coil to not deploy.Additionally, under sizing of the coil respective to the vessel size can cause the coil to not deploy as well although none of these potential factors could be confirmed.Per the quality engineering risk assessment, no further action is required cook will continue to monitor for similar complaints this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: RETRACTA DETACHABLE EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8334947
• Report Number: 1820334-2019-00274
• Device Sequence Number: 2357641
• Product Code: KRD
• UDI-Device Identifier: 10827002342009
• UDI-Public: (01)10827002342009(17)230419(10)8759251
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2023
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-14-12
• Device Lot Number: 8759251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other