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

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.

• 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: 5994828
• MDR Text Key: 56307367
• Report Number: 1219856-2016-00230
• 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: 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 Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: N/A
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR