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

Catalog Number IAB-06840-U

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that according to the sales representative (sr), the intensive care unit (icu) manager stated that they had a problem with the intra-aortic balloon (iab) in the operating room.The icu manager wanted the sr to speak to the perfusionist who said that he believed he had a bad transducer and therefore a poor arterial pressure waveform.He thought he could have done troubleshooting with it if given a few minutes, but the surgeon elected to pull the catheter because he was concerned he might be in a false lumen.There was no reported patient harm.The patient did not receive another iab.Per the sr there was no reported delay or interruption in iabp therapy.Medical / surgical intervention was not required.

Manufacturer Narrative

(b)(4).Evaluation: no product was returned for evaluation.The specific serial number/lot number was not reported, but a device history record 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 poor ap (arterial pressure) waveform signal is not able to be confirmed.The root cause of the complaint is undetermined.

Event Description

It was reported that according to the sales representative (sr), the intensive care unit (icu) manager stated that they had a problem with the intra-aortic balloon (iab) in the operating room.The icu manager wanted the sr to speak to the perfusionist who said that he believed he had a bad transducer and therefore a poor arterial pressure waveform.He thought he could have done troubleshooting with it if given a few minutes, but the surgeon elected to pull the catheter because he was concerned he might be in a false lumen.There was no reported patient harm.The patient did not receive another iab.Per the sr there was no reported delay or interruption in iabp therapy.Medical / surgical intervention was not required.

• 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: 5510416
• MDR Text Key: 40670043
• Report Number: 1219856-2016-00071
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/27/2016
• 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