MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-06840-U

Device Problem Fluid/Blood Leak (1250)

Patient Problems Cardiopulmonary Arrest (1765); Cognitive Changes (2551); Blood Loss (2597)

Event Date 08/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample not returned to manufacturer.

Event Description

It was reported that the event involved a patient 178cm in height in for a ventricular assist device (vad) workup.Originally, the catheter was placed via the femoral, later changed (b)(6) to axillary to provide ambulation for patient.Patient experienced gushing blood in balloon catheter tubing, (competitors) pump was removed from service due to likely bleed back in to pump.The customer was not aware of gas loss alarm before or after.The gas loss alarm may alert the registered nurse to blood in the catheter.The catheter was replaced within 30 minutes.The next iab was inserted via the patient's left axillary using the arrow flex sheath.The insertion was successful.There was no reported patient death or injury.The complications were described as "the patient was required to undergo additional procedure with sedation to removal and replacement the balloon catheter.Pump strips were generated and are not available for review.X-rays were performed daily and are not available for review.The interruption in iabp therapy is listed as 30 minutes.

Manufacturer Narrative

Qn#(b)(4).No product was returned for evaluation.A device history record (dhr) review was conducted for the serial/lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported that the event involved a patient 178cm in height in for a ventricular assist device (vad) workup.Originally, the catheter was placed via the femoral, later changed ((b)(6)) to axillary to provide ambulation for patient.Patient experienced gushing blood in balloon catheter tubing, (competitors) pump was removed from service due to likely bleed back in to pump.The customer was not aware of gas loss alarm before or after.The gas loss alarm may alert the registered nurse to blood in the catheter.The catheter was replaced within 30 minutes.The next iab was inserted via the patient's left axillary using the arrow flex sheath.The insertion was successful.There was no reported patient death or injury.The complications were described as "the patient was required to undergo additional procedure with sedation to removal and replacement the balloon catheter.Pump strips were generated and are not available for review.X-rays were performed daily and are not available for review.The interruption in iabp therapy is listed as 30 minutes.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5939508
• MDR Text Key: 54323567
• Report Number: 1219856-2016-00198
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F15J0056
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2015
• 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 Age: 50 YR
• Patient Weight: 78