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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-06830-U
Device Problems Fluid Leak (1250); Gas 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.
 
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Brand NameULTRAFLEX IAB: 7.5FR 30CC
Type of DeviceINTRA- 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 Key5918748
MDR Text Key53624563
Report Number1219856-2016-00197
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received08/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIAB-06830-U
Other Device ID Number00801902003751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2016
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 Treatment Data
Date Received: 08/31/2016 Patient Sequence Number: 1
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