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

Catalog Number IAB-05840-LWS

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call that there is a patient in the cath lab and the medical doctor placed a 40 cc fiber-optic intra-aortic balloon (iab) to support the patient for surgery tomorrow.The patient is (b)(6), and in sinus rhythm with a heart rate of 85 beats per minute (bpm) and no vasopressors infusing.The physician initially tried to place the balloon sheath-less into the right femoral artery.The physician felt that the guidewire was not supportive enough to advance the balloon and he had difficulty with the insertion.He removed the balloon and then decide to insert a second intra-aortic balloon (iab) using the sheath.He used the same site for the sheathed insertion.There was no report in death or complications to the patient.A report in delay of therapy but no harm caused to the patient.Outcome of the patient: being supported on the iab.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for analysis therefore the reported complaint of tight over guidewire is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.Other remarks: see mdr #1219856-2017-00136 and tc #(b)(4) associated with this report.

Event Description

It was reported via a hot line call that there is a patient in the cath lab and the medical doctor placed a 40 cc fiber-optic intra-aortic balloon (iab) to support the patient for surgery tomorrow.The patient is 5' 9" height, and in sinus rhythm with a heart rate of 85 beats per minute (bpm) and no vasopressors infusing.The physician initially tried to place the balloon sheath-less into the right femoral artery.The physician felt that the guidewire was not supportive enough to advance the balloon and he had difficulty with the insertion.He removed the balloon and then decide to insert a second intra-aortic balloon (iab) using the sheath.He used the same site for the sheathed insertion.There was no report in death or complications to the patient.A report in delay of therapy but no harm caused to the patient.Outcome of the patient: being supported on the iab.

• 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.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6669820
• MDR Text Key: 78475224
• Report Number: 1219856-2017-00135
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2017
• 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