MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06840-U

Device Problems Complete Blockage (1094); Difficult to Flush (1251)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4). For complaint related to the same patient and event see mdr #3010532612-2019-00329 and (b)(4).

Event Description

It was reported by the rn that the central lumen on the intra-aortic balloon (iab) is clotted. The rn stated that they are losing the arterial pressure (ap) waveform on the iab. The rn was not able to draw any blood back, and it would not flush. Patient is stable and scheduled to have the iab removed tomorrow. They were using saline only in the pressure bag, but the patient was systemically heparinized. As a result, an alternate a line will be inserted. There was no report of delay in therapy. There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of iab central lumen occluded is not able to be confirmed. The root cause of the complaint is undetermined. If the product is returned at a later date, a full investigation of the sample will be completed. 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. The reported complaint will be monitored for any developing trends. No further action required at this time. Other remarks: for complaint related to the same patient and event see mdr #3010532612-2019-00329 and tc #(b)(4).

Event Description

It was reported by the rn that the central lumen on the intra-aortic balloon (iab) is clotted. The rn stated that they are losing the arterial pressure (ap) waveform on the iab. The rn was not able to draw any blood back, and it would not flush. Patient is stable and scheduled to have the iab removed tomorrow. They were using saline only in the pressure bag, but the patient was systemically heparinized. As a result, an alternate a line will be inserted. There was no report of delay in therapy. There was no report of patient complications, serious injury or death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8947043
• MDR Text Key: 156112090
• Report Number: 3010532612-2019-00303
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2019
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F17L0046
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No