MAUDE Adverse Event Report: COOK INC CANTATA 2.8 SUPERSELECTIVE MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
Customer reported that a cantata 2.8 superselective microcatheter was being used for an unspecified procedure.The customer stated that the hub of the device came apart.There are no reported adverse patient consequences.The attending radiologist stated "i don't think this was defective.I think it was user error." no further information was provided.The device is reportedly available for evaluation, however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
A review of device history record, manufacturing instructions, quality control documents, specification, instructions for use (ifu), complaint history was conducted during the investigation.The manufacturing documents were in place at the time of manufacture were reviewed and it was found that the device aspect in question was visually and manually inspected by quality control.The risk specification for this product includes the failure mode "bond with inadequate tensile strength" and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.The device history record for the lot number was reviewed and no related non-conformances were identified.A search of our complaint records indicates that this is the only compliant on the lot number at the time of investigation.The product was not returned.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this complaint was driven by a procedural or device related cause.However, as it was reported by the customer that they believe "user error" was responsible for the reported failure mode, the root cause will be trended as such.Appropriate personnel have been notified and will continue to monitor for similar complaints.According to a quality engineering risk assessment no further action is required.

• Brand Name: CANTATA 2.8 SUPERSELECTIVE MICROCATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6508364
• Report Number: 1820334-2017-00644
• Device Sequence Number: 13605369
• Product Code: KRA
• UDI-Device Identifier: 10827002545349
• UDI-Public: (01)10827002545349(17)190713(10)7563529
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MCS-2.8-NT-110-15-HP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1