MAUDE Adverse Event Report: COOK INC FEMORAL ARTERY PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	10/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported a patient required puncture of the right femoral artery under seldinger's technique for the installation of invasive blood pressure.The guidewire was passed and the catheter was placed.The guidewire was removed, it came out disintegrating, preventing the complete removal of the guidewire, necessitating removal of the entire catheter.The guide wire was reported to be twice as large as its original size.A new kit was used to complete placement of the catheter.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Corrected data: recall and repair were incorrectly selected in the previous report.Investigation - evaluation.A review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, quality control, and photographs was conducted during the investigation.Photographs of only the wire were provided by the site.The photographs clearly revealed that the coiled portion of the wire has, at least in part, unraveled from the fixed core, but the images lack clarity and resolution to determine how much has unraveled or whether a wire, weld, or solder joint may have failed.Without the returned device, the catheter tip inner diameter (id) cannot be confirmed, nor can the needle id or dilator id be confirmed to be within specification.The various dimensions of wire length, wire diameter, solder and weld length cannot be compared to the established specifications for verification.A document-based investigation evaluation was also performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of the complaint history, device history record, manufacturing instructions, quality control data, and specifications was conducted during the investigation.The complaint device was not returned, therefore device failure analysis and physical examination could not be performed.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: FEMORAL ARTERY PRESSURE MONITORING SET
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6202396
• Report Number: 1820334-2016-01559
• Device Sequence Number: 10977255
• Product Code: DQO
• UDI-Device Identifier: 00827002019096
• UDI-Public: (01)00827002019096(17)190321(10)6830390
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-400-FA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: 06/28/2017; 09/07/2017
• Initial Report FDA Received Date: 12/23/2016
• Supplement Report FDA Received Date: 08/17/2017; 09/07/2017
• 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: Required Intervention