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

Catalog Number IAB-06840-U

Device Problem Material Rupture (1546)

Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 01/16/2016

Event Type  Death  

Manufacturer Narrative

(b)(4) sample will not be returned for evaluation.

Event Description

It was reported via a hotline call at 0551; first call, no answer.Message left at 0554.When the clinical support specialist (css) returned the call to the cath lab rn, she told the css, "never mind, we've got it" and hung up.At 0634 there was a direct call to the css's cell.The css was told the md wanted the number of their sales representative (sr) the cath lab stated they had told the md that the css had called from florida; however, he wanted the area sr.The css explained that she would gladly provide the sr number, but the css explained that she was the only one on call and they may be unable to reach the sr.The css asked if she could help in any way or answer any questions.They stated they would give the md her number.The css persisted and was finally told that the intra-aortic balloon (iab) ruptured and they were removing it.They were assuming the md wanted the sr at the bedside.The css explained it was not possible, but again the css would be glad to assist.They told the css they would let the md know.The md had gone to get a fem stop so that they can use it post removal.The css stressed that the iab must be removed asap to prevent entrapment or clotting.They stated they were aware and had informed the md of this.The css received no follow up calls.The css attempted several times to call and left a voicemail requesting follow up on the number provided.The css also attempted to call the cath lab directly and got no answer.Additional information received on 27jan2016 stated the sr spoke to the rn who reported that while in the cath lab the iab was inserted via the patient's (pt) right femoral artery.The pt was in the intensive care unit when after 15 hours of counterpulsation the pump alarmed "balloon rupture alarm." per the rn the iab was removed.There was a delay / interruption in iabp therapy and it is unknown if the delay caused harm to the pt.There were pt complications described as the pt expired.Also the rn told the sr that medical / surgical intervention was required to remove the iab.It is unknown if the event contributed to the death of the pt.

Manufacturer Narrative

(b)(4).Additional information: added lot number and expiration date and device manufacture date.Device evaluation: no product was returned for evaluation.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of leak suspected is not able to be confirmed.The root cause of the complaint is undetermined.

Event Description

It was reported via a hotline call at 0551; first call, no answer.Message left at 0554.When the clinical support specialist (css) returned the call to the cath lab rn, she told the css, "never mind, we've got it" and hung up.At 0634 there was a direct call to the css's cell.The css was told the md wanted the number of their sales representative (sr).The cath lab stated they had told the md that the css had called from (b)(6); however, he wanted the area sr.The css explained that she would gladly provide the sr number, but the css explained that she was the only one on call and they may be unable to reach the sr.The css asked if she could help in any way or answer any questions.They stated they would give the md her number.The css persisted and was finally told that the intra-aortic balloon (iab) ruptured and they were removing it.They were assuming the md wanted the sr at the bedside.The css explained it was not possible, but again the css would be glad to assist.They told the css they would let the md know.The md had gone to get a fem stop so that they can use it post removal.The css stressed that the iab must be removed asap to prevent entrapment or clotting.They stated they were aware and had informed the md of this.The css received no follow up calls.The css attempted several times to call and left a voicemail requesting follow up on the number provided.The css also attempted to call the cath lab directly and got no answer.Additional information received on 27jan2016 stated the sr spoke to the rn who reported that while in the cath lab the iab was inserted via the patient's (pt) right femoral artery.The pt was in the intensive care unit when after 15 hours of counterpulsation the pump alarmed "balloon rupture alarm." per the rn the iab was removed.There was a delay / interruption in iabp therapy and it is unknown if the delay caused harm to the pt.There were pt complications described as the pt expired.Also the rn told the sr that medical / surgical intervention was required to remove the iab.It is unknown if the event contributed to the death of the pt.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5398688
• MDR Text Key: 37103081
• Report Number: 1219856-2016-00028
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F15H0020
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 57