MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC

Catalog Number IAB-05840-LWS

Device Problems Device Alarm System (1012); Failure to Unfold or Unwrap (1669)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: for related complaint see mdr #1219856-2017-00316 and tc #(b)(4).

Event Description

It was reported by the rn that a second intra-aortic balloon (iab) was easily inserted and went to standby and on.The rn told the clinical support specialist (css) that the iab still would not unwrap.The rn tried again and said it "seems to be working now" but the pump started to alarm again.The rn commented to the md that it must be the patient.The md decided to remove the catheter and that the patient was stable.There were no reported patient complications and no reported patient death or serious injury.No medical intervention was required.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint that the balloon did not unwrap properly is not confirmed.Although, the root cause of the complaint remains undetermined the device passed all functional testing.The iab was pump tested and no alarms occurred.No further action required.For related complaint see mdr #1219856-2017-00316 and tc # (b)(4).

Event Description

It was reported by the rn that a second intra-aortic balloon (iab) was easily inserted and went to standby and on.The rn told the clinical support specialist (css) that the iab still would not unwrap.The rn tried again and said it "seems to be working now" but the pump started to alarm again.The rn commented to the md that it must be the patient.The md decided to remove the catheter and that the patient was stable.There were no reported patient complications and no reported patient death or serious injury.No medical intervention was required.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• 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: 7145544
• MDR Text Key: 95856140
• Report Number: 1219856-2017-00317
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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