MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Heart Failure (2206); Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after 5 days of usage the customer found that the balloon was broken.While removing the catheter the broken balloon was stuck in the body.The customer performed another procedure to remove it 2 days after.Patient outcome: under observation.There was no report of patient death.

Manufacturer Narrative

Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of removal difficulty is confirmed.The iab was returned with a damaged bladder consistent with removal difficulty.During the investigation, blood was confirmed within the iab helium pathway.The cause of how the blood entered the helium pathway was unable to be determined due to the returned state of the device.The root cause of how the blood entered the helium pathway 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 issue will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that after 5 days of usage the customer found that the balloon was broken.While removing the catheter the broken balloon was stuck in the body.The customer performed another procedure to remove it 2 days after.Patient outcome: under observation.There was no report of patient death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7464359
• MDR Text Key: 106604501
• Report Number: 3010532612-2018-00094
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F17L0039
• Other Device ID Number: 00801902003751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 45