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

Catalog Number IAB-05840-U

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) sample will not be returned for evaluation.

Event Description

It was reported that while in the cath lab the intra-aortic balloon (iab) was prepped and inserted via the patient's right femoral artery using the sheath with the sidearm.After insertion they were unable to draw back on the central lumen.The md suspected a kink in the central lumen.He was able to put a spring wire guide (swg) in and reposition the iab so that was not the case and subsequently still could not draw back through the central lumen.The iab was discontinued and it was replaced.There was no reported patient death, injury or complications.It is unknown if there was a delay / interruption in iabp therapy.Medical / surgical intervention was not required.The second iab was inserted into the same insertion site.Additional information received from the sales representative stated that there were no patient complications.

Manufacturer Narrative

(b)(4).Evaluation: no product was returned for evaluation.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of central lumen occluded is not able to be confirmed.The root cause of the complaint is undetermined.

Event Description

It was reported that while in the cath lab the intra-aortic balloon (iab) was prepped and inserted via the patient's right femoral artery using the sheath with the sidearm.After insertion they were unable to draw back on the central lumen.The md suspected a kink in the central lumen.He was able to put a spring wire guide (swg) in and reposition the iab so that was not the case and subsequently still could not draw back through the central lumen.The iab was discontinued and it was replaced.There was no reported patient death, injury or complications.It is unknown if there was a delay / interruption in iabp therapy.Medical / surgical intervention was not required.The second iab was inserted into the same insertion site.Additional information received from the sales representative stated that there were no patient complications.

• Brand Name: ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5265298
• MDR Text Key: 32641586
• Report Number: 1219856-2015-00265
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

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: 04/30/2017
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F15D0037
• Other Device ID Number: 00801902010759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2015
• 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