MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; INTRA- AORTIC BALLOON FIBER OPTIC

Catalog Number IAB-05830-LWS

Device Problems Inflation Problem (1310); Increase in Pressure (1491); Obstruction of Flow (2423)

Patient Problems Death (1802); Cardiogenic Shock (2262); Chest Tightness/Pressure (2463)

Event Date 01/23/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that in an emergency case in coronarographic lab the counter-pulsation device gave off an alarm sound with the message indicating "balloon pressure too high".The balloon was exchanged and the device did not recognize the optical fiber, balloon is changed again and the problem is the same.The patient did not have the best chance possible.This is the second incident in few months, which has already been declared.Additional information received on 1/27/17: it was reported that an ambulance was called for a patient in critical condition.The medical staff started the process with a 30cc intra-aortic balloon (iab) balloon.The device worked for 10 minutes.Then the counter-pulsation device gave off an alarm sound with the message indicating "balloon pressure too high".The connectors were checked and they were properly functional.The device was still working.The balloon was changed with a 40cc iab balloon.The device did not recognize the optical fiber.They changed the balloon with another 40cc balloon, the same problem occurred.The patient was in a critical condition and the use of the balloon was a last chance attempt.

Manufacturer Narrative

(b)(4).Teleflex received the reported device for analysis.The high pressure alarm was unable to be duplicated during functional testing.The iab passed functional testing therefore, the root cause of the reported complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.

Event Description

It was reported that in an emergency case in coronarographic lab the counter-pulsation device gave off an alarm sound with the message indicating "balloon pressure too high".The balloon was exchanged and the device did not recognize the optical fiber, balloon is changed again and the problem is the same.The patient did not have the best chance possible.This is the second incident in few months, which has already been declared.Additional information received on 1/27/2017: it was reported that an ambulance was called for a patient in critical condition.The medical staff started the process with a 30 cc intra-aortic balloon (iab) balloon.The device worked for 10 minutes.Then the counter-pulsation device gave off an alarm sound with the message indicating "balloon pressure too high".The connectors were checked and they were properly functional.The device was still working.The balloon was changed with a 40 cc iab balloon.The device did not recognize the optical fiber.They changed the balloon with another 40 cc balloon, the same problem occurred.The patient was in a critical condition and the use of the balloon was a last chance attempt.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6296959
• MDR Text Key: 66383893
• Report Number: 1219856-2017-00025
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

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 Expiration Date: 05/31/2018
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F16E0026
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 70