MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 7.5 FR - 30 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-06830-U

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

Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

It was reported that the event involved a pt with the possibility of tortuous vessels as well as medium calcification.While i the cath lab the intra-aortic balloon (iab) was pulled negative prior to insertion.The md inserted the sheath into the patient's left femoral artery.While inserting the iab into the sheath resistance was met and as a result, the md could not insert the iab through the sheath.The md requested another iab (different product number) for insertion.There was no reported pt death, injury or complications.There was no reported delay/interruption in iabp therapy.Medical/surgical intervention was not required.The pt outcome is listed as good.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 7.5 FR - 30 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 assoc. ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3881071
• MDR Text Key: 17295610
• Report Number: 1219856-2014-00073
• 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: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: KF3035340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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: 68 YR