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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-06840-U
Device Problem Connection Problem (2900)
Patient Problems Death (1802); Regurgitation (2259)
Event Date 09/12/2016
Event Type  Death  
Manufacturer Narrative
(b)(4) sample not returned to manufacturer.
 
Event Description
It was reported by the sales rep. That an intra-aortic balloon catheter (iab) was inserted via the patient's right femoral. The intra- aortic balloon pump display was "pixilated" no augmentation, occurred immediately. The perfusionist switched iabp consoles and there was no augmentation. The operating room manager questioned a "bump" on the arterial pressure waveform. The perfusionist said the balloon was inflating, borderline high pressure for the patient. There was no augmentation at all, no change in arterial waveform, placement was questioned. The transesophageal echo (tee) showed iab tip at the correct level. No strips or recording saved. The or manager said that the md thought the patient expiring was a patient issue. Additional information received on 09/30/2016 from the sales rep during in-service. It appears that they hooked up the competitors tubing rather than the arrow helium tubing and had multiple helium alarms. They saw the pump pumping but had no augmentation - it would have been pumping at the 2. 5cc volume rather than 40cc.
 
Manufacturer Narrative
(b)(4) no product was returned for evaluation. According to the event details, the service rep found that the incorrect inflation driveline tubing had been used. The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings. All devices passed all manufacturing specifications prior to release. Conclusion: the reported complaint of augmentation difficultly is not able to be confirmed. No product was returned for evaluation. According to the event details, the service rep found that the incorrect inflation driveline tubing had been used and could potentially have caused the reported complaint.
 
Event Description
It was reported by the sales rep. That an intra-aortic balloon catheter (iab) was inserted via the patient's right femoral. The intra- aortic balloon pump display was "pixelated" no augmentation, occurred immediately. The perfusionist switched iabp consoles and there was no augmentation. The operating room manager questioned a "bump" on the arterial pressure waveform. The perfusionist said the balloon was inflating, borderline high pressure for the patient. There was no augmentation at all, no change in arterial waveform, placement was questioned. The transesophageal echo (tee) showed iab tip at the correct level. No strips or recording saved. The or manager said that the md thought the patient expiring was a patient issue. Additional information received on 09/30/2016 from the sales rep during in-service. It appears that they hooked up the competitors tubing rather than the arrow helium tubing and had multiple helium alarms. They saw the pump pumping but had no augmentation - it would have been pumping at the 2. 5cc volume rather than 40cc.
 
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Brand NameULTRAFLEX IAB: 7.5FR 40CC
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 Key5994828
MDR Text Key56307367
Report Number1219856-2016-00230
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIAB-06840-U
Device Lot NumberN/A
Other Device ID Number00801902026804
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 Received11/08/2016
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: 10/03/2016 Patient Sequence Number: 1
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