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

Model Number N/A

Device Problems Misassembled (1398); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); No Code Available (3191)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

Event is still under investigation.

Event Description

During an unknown procedure, it was noted that the guidewire had been placed backwards in the guide wire holder and as a result, the wire punctured the arterial wall of the patient.The injury was described as minor as the user just had to stem the flow of bleeding.The patient did not require any additional procedures not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation- a review of the complaint history, quality control(qc), specifications and a visual inspection of the complaint device was conducted for the purpose of this investigation.The supplied wire guide from the c-pms-400-ra, radial artery pressure monitoring set having a product label lot number consisting of 4351386 was returned in an opened and used condition.A visual examination confirmed that one end had a flexible tip with the proximal end having a stiff end.The wire was returned having the flexible tip extending from the single loop holder.The flexible end of the wire guide is extending out of the holder which is the correct positioning.Visual examination reveals that there is some blood on both ends of the returned wire guide and there is a kink 10.4 cm from the flexible end of the wire.The customer stated that the guidewire was manufactured backwards resulting in perforation of the vessel.Based on customer statement it is feasible that the wire guide was placed in the holder with the proximal rather than the distal end extending out of the holder.Per specifications wire guide holder and inserter usage for sf wire guides "5 cm of distal end of guide should extend out of holder".Instructions are in place to verify that the device is manufactured within specifications.Qc instructions are in place to test and inspect the device for any non-conformance.The device history records (dhr) were reviewed and noted two non-conformities within the manufacturing department.A review of the nonconformance data revealed that there was nonconformance's on the dhr identified for a bent and large weld.These recorded nonconformance's would have been discarded or repaired prior to further processing.Based on this information, the root cause for this noncomformance is manufacturing related.Production personnel have been notified.

Event Description

During an unknown procedure, it was noted that the guidewire had been placed backwards in the guide wire holder and as a result, the wire punctured the arterial wall of the patient.The injury was described as minor as the user just had to stem the flow of bleeding.The patient did not require any additional procedures not experience any adverse effects due to this occurrence.

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5261454
• MDR Text Key: 32559708
• Report Number: 1820334-2015-00822
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-400-RA
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2015
• Device Age: 25 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other