MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: THERMISTOR 7 110CM; BALLOON THERMODILUTION CATHETER PROD

Catalog Number AI-07167

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use (the catheter via the jugular) the tip of the catheter there is no registration of the waves of pressure from the intravascular and had lost of continuity of the catheter approximately 4 cm from the tip.The device was removed and not replaced.There was a delay/interruption in therapy.There was no death, injury or complications to the patient.

Manufacturer Narrative

(b)(4) device evaluation: a 7fr thermodilution balloon catheter was returned for evaluation.The catheter was visually inspected and no damage, abnormalities, or kinks were noted.The volume limitation of the balloon was noted to be 1.5cc.No syringe was returned with the kit.The inflation lumen was injected with 1.5cc of air using a lab inventory syringe.The balloon inflated within specification.The balloon deflated within three seconds and was within specification.A spring wire guide (swg) was inserted through the distal lumen of the catheter and it advanced with no resistance.No blood or debris exited with the swg.The catheter was inserted into the t-tube and connected to the transducer via the distal lumen.The t-tube was pressurized to 65 mmhg.A pressure reading was able to be read through the lumen and transducer.A device history record review was not performed.Conclusion: there was no confirmed product failure with the returned sample.The reported complaint of no pressure reading is not confirmed.The catheter passed functional testing.The root cause of the complaint is undetermined.

Event Description

It was reported that during use (the catheter via the jugular) the tip of the catheter there is no registration of the waves of pressure from the intravascular and had lost of continuity of the catheter approximately 4 cm from the tip.The device was removed and not replaced.There was a delay/interruption in therapy.There was no death, injury or complications to the patient.

• Brand Name: CATH PKGD: THERMISTOR 7 110CM
• Type of Device: BALLOON THERMODILUTION CATHETER PROD
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5127211
• MDR Text Key: 27454451
• Report Number: 3010532612-2015-00026
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K823433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• 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-07167
• Device Lot Number: 16F14J0101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2014
• 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