MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-S840C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Venipuncture (2129); No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that in the department of cardiology the "doctor complained that during use of the intra-aortic balloon (iab) on a patient the heparin connector of the iab had leakage which cause patients bleeding.The doctor replaced a new one to conduct the treatment".There was a reported delay and or interruption in therapy but unknown if the delay caused harm to the patient.The first iab was inserted via the left femoral artery and the second iab was inserted via the right femoral artery.There was no reported patient death, injury or complications.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint that there was a leak at the hub of the central lumen is confirmed.Although, the root cause is undetermined during functional testing, a crack was found at the injection site of the bifurcate for the central lumen.This crack allowed a leak to occur at the injection site of the central lumen.A device history record (dhr) review was conducted for the lot number/serial 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 risks.This issue will be monitored for developing trends.

Event Description

It was reported that in the department of cardiology the "doctor complained that during use of the intra-aortic balloon (iab) on a patient the heparin connector of the iab had leakage which cause patients bleeding.The doctor replaced a new one to conduct the treatment".There was a reported delay and or interruption in therapy but unknown if the delay caused harm to the patient.The first iab was inserted via the left femoral artery and the second iab was inserted via the right femoral artery.There was no reported patient death, injury or complications.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• 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: 6611147
• MDR Text Key: 76659104
• Report Number: 1219856-2017-00127
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F16J0027
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/05/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• 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