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

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
The international customer reported that, when the retracta detachable embolization coil was advanced through the angiodynamics sos angiographic catheter, it was discovered that the coil had disconnected.The procedure pertained to the common iliac ansatomosis vessel leak connecting to transplanted kidney.The customer reported that torqueing of the delivery wire was ruled out as a cause of the issue.The customer additionally confirmed that the product problem did not result in any adverse patient effects, and did not necessitate any additional procedure.The product has been received for evaluation and per photographs attached, the embolization coil has elongated.As of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, dimensional verification, documentation, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the microcoil was severely stretched.The outside diameter of the coil, the detachable coil delivery wire proximal coil outer diameter, outside diameter of centerless ground mandril, and detachable coil delivery wire distal coil outer diameter were all found to be within specification.Based on the information above, it was determined that there is no evidence to suggest that the device was not manufactured to specification and there is no evidence to suggest this failure was manufacturing related.Likely the stretched condition of the micro-coil is due to removal of the coil from the catheter or patient after it prematurely deployed.Additionally, a document based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.We will note that based on a review of the product information page for the sos omni selective catheter, the catheter is available both with and without sideports.It is unclear which type was used in this procedure.The ifu warns against using catheters with sideports.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints and have notified the appropriate personnel about this event.Per the quality engineering risk assessment no further action is required.

• 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: 7264741
• Report Number: 1820334-2018-00158
• Device Sequence Number: 13816812
• Product Code: KRD
• UDI-Device Identifier: 10827002342009
• UDI-Public: (01)10827002342009(17)211018(10)7322906
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-14-12
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOS OMNI SELECTIVE CATHETER