MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; INTRA- AORTIC BALLOON

Catalog Number IAB-S730C

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Cardiogenic Shock (2262)

Event Date 04/05/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported: patient of (b)(6) in height with an important prolonged cardiopulmonary bypass (cpb) due to surgical size.The invasive pressure measurements through the balloon intra-aortic (bia) were the same on 03 different monitors.All attempts failed to register.This lack of registration influenced medical decisions.The distal lumen was perfused with serum to remove any obstruction.Used as an extracorporeal circulation, bia treatment was initiated, and at this time it was identified that the distal catheter pathway did not record invasive pressure measurements, a fact that could be influencing medical decisions.Medical intervention required: attempt to reposition of the catheter insertion site: right femoral artery.

Manufacturer Narrative

(b)(4).Teleflex received the device for evaluation.The reported complaint of central lumen occluded is confirmed.The aspiration/flushing test was successful.The actual root cause could not be determined but a kink and bend was noted to the iab central lumen, which is the probable cause of the reported complaint.A device history record (dhr) review was conducted with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint and there are no new or revised risks.We will continue to monitor for developing trends.

Event Description

It was reported: patient of (b)(6) in height with an important prolonged cardiopulmonary bypass (cpb) due to surgical size.The invasive pressure measurements through the balloon intra-aortic (bia) were the same on 03 different monitors.All attempts failed to register.This lack of registration influenced medical decisions.The distal lumen was perfused with serum to remove any obstruction.Used as an extracorporeal circulation, bia treatment was initiated, and at this time it was identified that the distal catheter pathway did not record invasive pressure measurements, a fact that could be influencing medical decisions.Medical intervention required: attempt to reposition of the catheter insertion site: right femoral artery.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: INTRA- AORTIC BALLOON
• 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: 6538861
• MDR Text Key: 74235337
• Report Number: 1219856-2017-00080
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F16C0042
• Other Device ID Number: 00801902002686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• 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: 66 YR
• Patient Weight: 45