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

Catalog Number IAB-06840-U

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an intra-aortic balloon (iab) was placed in a patient of 164cm in height via the right femoral artery.Difficulty was encountered when advancing the iab into the sheath.The medical doctor removed the catheter and replaced with another catheter to the same insertion site.There was no report in patient death or complications.A report of delay in therapy but no harm caused to the patient.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint of catheter stuck in sheath is not confirmed.The teflon sheath was removed from the iab without any damage found to the iab or any potential causes for difficulty.Both the sheath and iab bladder passed dimensional specifications.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.

Event Description

It was reported that an intra-aortic balloon (iab) was placed in a patient of (b)(6)cm in height via the right femoral artery.Difficulty was encountered when advancing the iab into the sheath.The medical doctor removed the catheter and replaced with another catheter to the same insertion site.There was no report in patient death or complications.A report of delay in therapy but no harm caused to the patient.

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: 6677268
• MDR Text Key: 78705065
• Report Number: 1219856-2017-00137
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F17C0016
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• 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
• Patient Age: 80 YR
• Patient Weight: 74