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

Model Number N/A

Device Problems Break (1069); Component(s), broken (1103)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2014

Event Type  malfunction  

Event Description

Information was provided that the ulnar arterial line was being rewired.The wire fed easily through the introducer that was insitu.The introducer was removed then new arterial introducer fed over the wire.It fed easily; however, when the resident tried to withdraw the wire through the introducer, he noticed some resistance and that the wire had unraveled and broken in one place.Kelly clamps applied to broken end and on catheter (introducer) itself.Catheter slowly withdrawn as concern that the wire may break in another location.Once catheter removed, the tip of the wire was checked; which was present.Chest and upper arm x-ray done to ensure no pieces of wire were insitu.None were noted.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No additional information was provided regarding patient outcome.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Investigation: a review of complaint history, device history record, quality control, and a visual inspection of the returned device were conducted during the investigation.The product was returned in an opened and used condition.A visual inspection noted that the wire had unraveled and separated.The c-pms device had several indentations and kinks throughout the catheter shaft.There is no evidence to suggest that the product was not manufactured to specifications.We are unable to determine with certainty why this failure mode occurred.The appropriate internal personnel have been notified and we will continue to monitor for similar devices.Per the conclusion of quality engineering risk assessment, no further risk reduction is required.

Event Description

Information was provided that the ulnar arterial line was being rewired.The wire fed easily through the introducer that was insitu.The introducer was removed then new arterial introducer fed over the wire.It fed easily; however, when the resident tried to withdraw the wire through the introducer, he noticed some resistance and that the wire had unraveled and broken in one place.Kelly clamps applied to broken end and on catheter (introducer) itself.Catheter slowly withdrawn as concern that the wire may break in another location.Once catheter removed, the tip of the wire was checked; which was present.Chest and upper arm x-ray done to ensure no pieces of wire were insitu.None were noted.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).

Event Description

Information was provided that the ulnar arterial line was being rewired.The wire fed easily through the introducer that was insitu.The introducer was removed then new arterial introducer fed over the wire.It fed easily; however, when the resident tried to withdraw the wire through the introducer, he noticed some resistance and that the wire had unraveled and broken in one place.Kelly clamps applied to broken end and on catheter (introducer) itself.Catheter slowly withdrawn as concern that the wire may break in another location.Once catheter removed, the tip of the wire was checked; which was present.Chest and upper arm x-ray done to ensure no pieces of wire were insitu.None were noted.According to the initial reporter, the patient did 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4417553
• MDR Text Key: 5371054
• Report Number: 1820334-2015-00037
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2017
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-300-RA
• Device Lot Number: 5382763
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/25/2014
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/31/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• 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