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

Catalog Number IAB-05840-LWS

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the event occurred in the (b)(6) lab, during use on a patient. The fiber optic sensor (fos) adaptor could not be connected to the pump. Several attempts to connect the catheter to the pump by means of the blue fos adaptor has failed. Hospital staff tried to use more force to be able to connect the fos adaptor to the pump, but to no success. As a result, a new intra-aortic balloon (iab) catheter set was open and used successfully. There was no report of patient complication or serious injury and death.

Manufacturer Narrative

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

Event Description

It was reported the event occurred in the cath lab, during use on a patient. The fiber optic sensor (fos) adaptor could not be connected to the pump. Several attempts to connect the catheter to the pump by means of the blue fos adaptor has failed. Hospital staff tried to use more force to be able to connect the fos adaptor to the pump, but to no success. As a result, a new intra-aortic balloon (iab) catheter set was open and used successfully. There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of fos connection problem is not able to be confirmed. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint will be monitored for any developing trends. If the product is returned at a later date, a full investigation of the sample will be completed. No further action required at this time. Other remarks: this complaint has been reopened to investigate the device that has been returned to teleflex for investigation. The reported complaint of the iab fos connection problem is confirmed. The fos was returned with a recessed connector and the fiber was broken; therefore, a light path could not be established between the sensor and the pump. The root cause of the recessed fos and broken fiber is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. This will be monitored for any developing trends. No further action required at this time.

Event Description

It was reported the event occurred in the cath lab, during use on a patient. The fiber optic sensor (fos) adaptor could not be connected to the pump. Several attempts to connect the catheter to the pump by means of the blue fos adaptor has failed. Hospital staff tried to use more force to be able to connect the fos adaptor to the pump, but to no success. As a result, a new intra-aortic balloon (iab) catheter set was open and used successfully. There was no report of patient complication or serious injury and death.

• 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: 7411557
• MDR Text Key: 104890623
• Report Number: 3010532612-2018-00073
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17H0009
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial