MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-06830-U

Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)

Patient Problems Stroke/CVA (1770); Death (1802); Heart Failure (2206)

Event Date 08/13/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).See 1219856-2016-00185 for other event.The sample was discarded.

Event Description

It was reported that the event involves a patient (b)(6).Post previous rupture, patient was momentarily placed on arrow iabp pump, during which time a balloon occlusive measurement was taken.Measurement revealed correct balloon sizing (balloon pressure equaled augmented pressure.) the patient was switched back to competitors pump; patient later experienced blood in catheter tubing, described as acute.A gas loss alarm occurred, however, whether this occurred prior or post blood in catheter tubing is unknown.The patient was sent for balloon replacement; however, catheter remained in dwelling in patient for greater than 30 minute time period.It was reported that the second iab was inserted via the patients right axillary, percutaneous, sheathed.There was a delay/interruption in iabp therapy with intervention to removal and reinsertion a new balloon.There was reported patient complications as patient had a massive stroke during replacement and subsequent death.The pump alarmed "gas loss" pump strips were generated and are not available for review.X-rays were performed daily and are not available for review.The iab was not saved during exchange; patient was building resistant antibiotic organism.The insertion occurred in the cath lab and the event occurred in the cvicu.

Manufacturer Narrative

(b)(4).See 1219856-2016-00185 for other event.The product was not returned for evaluation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed.The product was not returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported that the event involves a patient (b)(6) in height.Post previous rupture, patient was momentarily placed on arrow iabp pump, during which time a balloon occlusive measurement was taken.Measurement revealed correct balloon sizing (balloon pressure equaled augmented pressure.) the patient was switched back to competitors pump; patient later experienced blood in catheter tubing, described as acute.A gas loss alarm occurred, however, whether this occurred prior or post blood in catheter tubing is unknown.The patient was sent for balloon replacement; however, catheter remained in dwelling in patient for greater than 30 minute time period.It was reported that the second iab was inserted via the patients right axillary, percutaneous, sheathed.There was a delay/interruption in iabp therapy with intervention to removal and reinsertion a new balloon.There was reported patient complications as patient had a massive stroke during replacement and subsequent death.The pump alarmed "gas loss" pump strips were generated and are not available for review.X-rays were performed daily and are not available for review.The iab was not saved during exchange; patient was building resistant antibiotic organism.The insertion occurred in the cath lab and the event occurred in the cvicu.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• 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: 5918748
• MDR Text Key: 53624563
• Report Number: 1219856-2016-00197
• 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: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06830-U
• Other Device ID Number: 00801902003751
• 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
• 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; Life Threatening; Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 68