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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient was scheduled to undergo an endovascular aortic aneurysm repair (evar).Embolization of the patient's internal iliac artery was indicated prior to the evar.One retracta detachable embolization coil was successfully deployed.A second coil appeared to become entangled in the first coil during deployment and the physician was unable to visualize the junction zone of the coil.Attempts to deploy the second coil by turning the pin vise and to remove the delivery wire were not successful.The physician noticed that the distal part of delivery wire had separated leaving the coil, junction zone and part of the delivery wire in the patient's artery.The coil mass was ballooned to set and maintain placement.The patient reportedly will undergo evar with a covered stent to shield the embolized portion of the internal iliac artery.No further patient or event information is available.The device was returned for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, device history record, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the delivery wire was snapped off, and the embolization coil was not present.The proximal coil was broken 7cm from the proximal solder, and with slight elongation/unraveling observed on the end of the coil.The distal solder and distal coil (where the retracta connects) were not present.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record indicated that the lot met all finished goods release criteria.It should be noted that there are no other complaints reported for this lot number.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.
Additional Manufacturer Narrative
(b)(4).

• 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: 6443055
• Report Number: 1820334-2017-00558
• Device Sequence Number: 13633246
• Product Code: KRD
• UDI-Device Identifier: 10827002341996
• UDI-Public: (01)10827002341996(17)210921(10)7264123
• 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,Followup
• Report Date (Section B): 05/16/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-14-10
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided; 04/11/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 05/02/2017; 05/16/2018
• 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