MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-S840C

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: (b)(4).

Event Description

It was reported that the event occurred in the cath lab.The medical doctor found it difficult to thread the iab over the guide wire however, the intra- aortic balloon catheter (iab) was inserted via the patient's right femoral artery sheathless.The iab was placed in the "arcus aorta".The medical doctor could not aspirate the central lumen and the md decided to remove the iab.According to the report the md found it difficult to insert the wire into the central lumen.There was no reported patient death or injury.There was a reported complication of being hemodynamically not stable.The intervention required was a ptca (percutaneous transluminal coronary angioplasty).The patient received a competitor's iab via the same insertion site successfully.

Manufacturer Narrative

Concomitant medical products: (b)(4).This mdr was submitted in error and is a duplicate of 1219856-2016-00113 initially submitted on (b)(6) 2016.

Event Description

It was reported that the event occurred in the cath lab.The md found it difficult to thread the iab over the guide wire however, the intra- aortic balloon catheter (iab) was inserted via the patient's right femoral artery sheathless.The iab was placed in the "arcus aorta".The md could not aspirate the central lumen and the md decided to remove the iab.According to the report the md found it difficult to insert the wire into the central lumen.There was no reported patient death or injury.There was a reported complication of being hemodynamically not stable.The intervention required was a ptca (percutaneous transluminal coronary angioplasty).The patient received a competitor's iab via the same insertion site successfully.

Manufacturer Narrative

Concomitant medical products: (b)(4).No product was returned for evaluation.A device history record (dhr) review was unable to be completed.No lot number was reported.The lot numbers at this account are unable to be retrieved at this time.When the dhr is completed, the complaint will be updated accordingly.The reported complaint of unable to aspirate/flush is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.If the sample is returned at a later date, a full investigation will be completed.

Event Description

It was reported that the event occurred in the cath lab.The md found it difficult to thread the iab over the guide wire however, the intra- aortic balloon catheter (iab) was inserted via the patient's right femoral artery sheathless.The iab was placed in the "arcus aorta".The md could not aspirate the central lumen and the md decided to remove the iab.According to the report the md found it difficult to insert the wire into the central lumen.There was no reported patient death or injury.There was a reported complication of being hemodynamically not stable.The intervention required was a ptca (percutaneous transluminal coronary angioplasty).The patient received a competitor's iab via the same insertion site successfully.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 6074696
• MDR Text Key: 59055983
• Report Number: 1219856-2016-00260
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K981660
• 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,Followup
• Report Date: 05/03/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-S840C
• Device Lot Number: N/A
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/30/2016; 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLAS
• Patient Outcome(s): Other
• Patient Age: 50 YR