MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05840-LWS

Device Problems Unable to Obtain Readings (1516); Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the cath lab they had a patient in a procedure and an intra-aortic balloon (iab) was just inserted.It was stated that the fiber "didn't work" and they "couldn't get a signal.The clinical support specialist (css) verified that the pump is now pumping, no alarms.The rn was unable to provide the css information at the time because she had to get back to the case.The css tempted to call back but was unable to reach anyone in the cath lab.A second call was received by a different registered nurse.The registered nurse is calling to discuss the iab size, the balloon plateau pressure, and the augmentation.It was discussed how to decrease the balloon volume and sizing which was appropriate.An md's order would be required.The registered nurse also discussed the fiber not working.The css explained that the pump would use the transducer.The rn felt the patient was receiving the goals of therapy.There were no reported patient deaths or complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of fos would not zero is not able to be confirmed.The root cause of the complaint is undetermined.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.If the sample is returned at a later date, a full investigation will be completed.No further action required at this time.

Event Description

It was reported by the cath lab they had a patient in a procedure and an intra-aortic balloon (iab) was just inserted.It was stated that the fiber "didn't work" and they "couldn't get a signal.The clinical support specialist (css) verified that the pump is now pumping, no alarms.The rn was unable to provide the css information at the time because she had to get back to the case.The css tempted to call back but was unable to reach anyone in the cath lab.A second call was received by a different rn.The rn is calling to discuss the iab size, the balloon plateau pressure, and the augme ntation.It was discussed how to decrease the balloon volume and sizing which was appropriate.An md's order would be required.The rn also discussed the fiber not working.The css explained that the pump would use the transducer.The rn felt the patient was receiving the goals of therapy.There were no reported patient deaths or complications.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7071656
• MDR Text Key: 93594974
• Report Number: 1219856-2017-00298
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: N/A
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• 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