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

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
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
The customer reported that, during a product demonstration, upon the opening of the retracta detachable embolization coil, the coil detached from the delivery wire as the wire was pushed out of the metal cannula for the first time.The wire was reportedly not torqued, and the coils were not held on to while the wire was advanced.The customer confirmed that the device was not used; accordingly, no patient adverse events occurred as a result of the product issue.The product is reportedly unavailable for return and evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of device history record, drawings, instructions for use (ifu), manufacturing instructions, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.The device history record (lot number 7020574 and relevant subassembly lot numbers) was reviewed and determined that no nonconformance's were recorded that could have contributed to this event.A search of our complaint records confirmed this complaint to be the only reported complaint for the lot.The device is thoroughly inspected during quality control inspection for dimensional and visual criteria.Risk documentation is in place that identifies the failure mode related to premature detachment of the coil.There is no evidence that the device was not manufactured to specification.The rep reported that during a demo, when the delivery wire was pushed out of the metal cannula presumably to show the embolization coil, the coil detached from the wire.The device is intended to be transferred from the metal cannula into a catheter.The catheter provides stability and securement to the coil/delivery wire junction.The ifu states that the junction between the coil and the delivery wire should remain inside the catheter.It is likely that the junction was unsupported during the demonstration, allowing the coil to detach from the delivery wire, or that the wire was inadvertently turned while pushing the delivery wire through the cannula.Based on the information provided, no product returned, and the results of our investigation; the root cause was determined to be related to product use and handling, the operational context in which it was used (demonstration).A risk assessment was not performed as this event had no patient-related implications and the device was likely used outside of its intended design.

• 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: 7081658
• Report Number: 1820334-2017-04232
• Device Sequence Number: 1495401
• Product Code: KRD
• UDI-Device Identifier: 10827002341873
• UDI-Public: (01)10827002341873(17)210718(10)7020574
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K123712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: Other
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-7-4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1