MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 7.5FR-40 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-06840-U

Device Problems Physical Resistance (2578); Device-Device Incompatibility (2919)

Patient Problem Myocardial Infarction (1969)

Event Date 03/08/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event involved a male patient while in the cath lab during insertion.It was stated that there was a possibility of the patient having a tortuous vessel and light calcification was noted.The md attempted to insert the intra-aortic balloon (iab-06840-u) through the teflon sheath via left femoral artery when resistance was met.As a result, the iab was removed and discarded.A new non teleflex kit was inserted into the patient's arm successfully for treatment.There was no report of patient death, complications or injury.No medical/surgical intervention ws required.There was an approx 30 minute delay or interruption in therapy with no harm to the patient.The patient outcome is good add'l info received on (b)(4) 2014 stated that it has been confirmed with the product manager that the user wets the balloon membrane but does not submerge in saline.

• Brand Name: IAB: 7.5FR-40 CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory assc. ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 3763391
• MDR Text Key: 19395203
• Report Number: 1219856-2014-00072
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: KF2073601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR