MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: THERMISTOR 6 FR 110 CM; BALLOON THERMODILUTION CATHETER PROD

Catalog Number AI-07365-HL

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

It has been reported that while in the cath lab the m.D.Inserted the catheter into the patient's right internal jugular.After insertion the m.D.Was unable to get a waveform from the catheter.As a result, a second (b)(4) was prepped and inserted and used without incident.There was a reported delay / interruption in therapy, however this did not cause harm to the patient.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.Patient outcome is fine.

Manufacturer Narrative

(b)(4).

• Brand Name: CATH PKGD: THERMISTOR 6 FR 110 CM
• Type of Device: BALLOON THERMODILUTION CATHETER PROD
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth dr; chelmsford MA 01824
• Manufacturer Contact: kathryn myers ; 2400 bernville rd.; reading, PA 19605 ; 6103780131
• MDR Report Key: 4511146
• MDR Text Key: 17262600
• Report Number: 3010532612-2015-00005
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: AI-07365-HL
• Device Lot Number: 16F14J0130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• 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
• Patient Age: 50 YR