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

Catalog Number IAB-05840-LWS

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: see related complaint (b)(4).

Event Description

It was reported by the rn that intra-aortic balloon (iab) catheter central lumen may be clotted.They have attempted to draw blood back and flush, but are not able to do either.The rn is calling to see if it is safe to leave the iab in like this.There is a radial a-line that is being used as the ap source for the pump, and the waveform is good.The clinical support specialist (css) and rn discussed capping the central lumen, and marking it as not to be accessed.There was no report of delay in therapy.No reported patient death or complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of central lumen occluded 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.No further action required at this time.Other remarks: see related complaint (b)(4).

Event Description

It was reported by the rn that intra-aortic balloon (iab) catheter central lumen may be clotted.They have attempted to draw blood back and flush, but are not able to do either.The rn is calling to see if it is safe to leave the iab in like this.There is a radial a-line that is being used as the ap source for the pump, and the waveform is good.The clinical support specialist (css) and rn discussed capping the central lumen, and marking it as not to be accessed.There was no report of delay in therapy.No reported patient death 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: 6986982
• MDR Text Key: 91118299
• Report Number: 1219856-2017-00247
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• 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