MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. THERMODILUTION CATH KIT: 7.5 FR 5-L; INTRODUCER, CATHETER

Catalog Number AH-05050-G

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the balloon wouldn t deflate automatically after connecting the attached syringe".They had to actively pull the air out with the syringe." additional information: the thermodilution catheter was tested before use with the syringe in the kit.There was no problems at this point.The problems occurred after insertion (into the patient).The device was not replaced.There was no reported patient death, injury or complications.There was no delay/interruption in therapy.Medical/surgical intervention was not required.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint of "the balloon wouldn t deflate" is not confirmed.The catheter balloon was successfully deflated after inflation.The device passed functional testing.The root cause of the complaint is undetermined.No further action required.

Event Description

It was reported that "the balloon wouldn't deflate automatically after connecting the attached syringe".They had to actively pull the air out with the syringe." additional information: the thermodilution catheter was tested before use with the syringe in the kit.There was no problems at this point.The problems occurred after insertion (into the patient).The device was not replaced.There was no reported patient death, injury or complications.There was no delay/interruption in therapy.Medical/surgical intervention was not required.

• Brand Name: THERMODILUTION CATH KIT: 7.5 FR 5-L
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6577172
• MDR Text Key: 75613610
• Report Number: 3006425876-2017-00158
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K895268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: AH-05050-G
• Device Lot Number: 71F16L0011
• Other Device ID Number: 10801902128895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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